Product identifier Product Name Caladryl Clear Relevant identified uses of the substance or mixture and uses advised against

Transcription

1 Safety Data Sheet Section 1: Identification Product identifier Product Name Caladryl Clear Relevant identified uses of the substance or mixture and uses advised against Recommended use Temporarily relieves pain and itching associated with rashes due poison ivy, poison oak, or poison sumac, insect bites, minor skin irritation, minor cuts. Dries the oozing and weeping of poison ivy, poison oak and poison sumac. Restrictions on use Use in accordance with product literature. Details of the supplier of the safety data sheet Manufacturer Valeant Pharmaceuticals North America, LLC Bridgewater, NJ United States valeant.com Telephone (General) Emergency telephone number Manufacturer US Infotrac Manufacturer International Infotrac This safety data sheet is written to provide health, safety and environmental information for people handling this formulated product in the workplace. It is not intended to provide information relevant to consumer use of the product. Section 2: Hazard Identification According to: UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Classification of the substance or mixture Eye Mild Irritation 2B Label elements WARNING Hazard statements May cause eye irritation Precautionary statements Prevention Use personal protective equipment as required. Wash thoroughly after handling. Response IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention. Storage/Disposal Keep tightly closed. Store at room temperature 20 25ºC (68 77ºF), to maintain product integrity. Use before date marked on carton and/or container. Page 1 of 9

2 Other hazards Section 3 Composition/Information on Ingredients Substances Mixtures Material does not meet the criteria of a substance according to United Nations Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Composition Chemical Name Identifiers % Classifications According to Regulation/Directive Camphor CAS: EINECS: N/A : Skin Irrit. 2; Eye Irrit. 2A Citric acid CAS: EINECS: N/A : Skin Irrit. 2; Eye Irrit. 2A; Acute Tox. Oral 5 Diazolidinyl urea CAS: EINECS: N/A : NDA Ethanol CAS: EINECS: < 5% : Skin Irrit. 2; Eye Irrit. 2A; Muta. 1B; Repr. 1B Glycerin CAS: EINECS: N/A : Skin Irrit. 3; Eye Irrit. 2B Hydroxypropyl methylcellulose CAS: N/A : NDA Lavender oil CAS: N/A : NDA Methylparaben CAS: EINECS: N/A : Skin Irrit. 2; Eye Irrit. 2A Polysorbate 40 CAS: N/A : NDA Pramoxine Hydrochloride CAS: EINECS: % : NDA Propylene Glycol CAS: EINECS: N/A : Skin Irrit. 3; Eye Irrit. 2B Propylparaben CAS: EINECS: N/A : NDA Rosemary oil CAS: N/A : NDA Sodium chloride CAS: EINECS: N/A : Skin Irrit. 2; Eye Irrit. 2A; Acute Tox. Oral 5 Sodium citrate CAS: N/A : Skin Irrit. 2; Eye Irrit. 2A Water CAS: EINECS: N/A : Classification Criteria Not Met Zinc acetate, dihydrate CAS: % : NDA N/A Designates that the chemical percentage of composition is not available as it is considered proprietary information. Section 4: First Aid Measures Description of first aid measures Inhalation No specific treatment is necessary since this material is not likely to be hazardous by Page 2 of 9

3 inhalation. If exposed to excessive levels of mists, remove to fresh air and get medical attention. Skin No specific treatment is necessary since this material is not likely to be hazardous by contact with the skin or mucous membranes. Eye IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention. Ingestion Call a physician or poison control center. Most important symptoms and effects, both acute and delayed Indication of any immediate medical attention and special treatment needed Other information Have the product container or label with you when calling a poison control center or doctor, or going for treatment. Section 5: Fire Fighting Measures Extinguishing media Suitable Extinguishing Media Water spray, carbon dioxide, dry chemical powder or appropriate foam for surrounding Unsuitable Extinguishing Media fire. Special hazards arising from the substance or mixture Unusual Fire and Explosion Hazards Hazardous Combustion Products Advice for firefighters None known product is not flammable or combustible. As in any fire, wear self contained breathing apparatus and full protective gear to prevent contact with skin and eyes. Section 6 Accidental Release Measures Personal precautions, protective equipment and emergency procedures Personal Precautions No special controls or personal protection required under conditions of intended use. In the event of bulk spills, wear suitable protective eyewear, clothing, protective boots and protective gloves. Refer to Section 8. Emergency Procedures No emergency procedures are expected to be necessary when used in accordance with product literature. Environmental precautions Methods and material for containment and cleaning up Containment/Clean up Measures Section 7 Handling and Storage Contain spilled product. For small spills, add suitable absorbent material. Scoop up and place in an appropriate liquid tight container equipped with a tight cover for disposal. For large spills, dike spilled material or otherwise contain material to ensure runoff does not reach a waterway. Place spilled material in an appropriate, liquid tight container equipped with a tight cover for disposal. Page 3 of 9

4 Precautions for safe handling Handling No special handling is required. Refer to Section 8. Use only in accordance with product literature. Conditions for safe storage, including any incompatibilities Storage Keep tightly closed and store in upright position. Store at room temperature 20 25ºC (68 77ºF). Section 8 Exposure Controls/Personal Protection Control parameters Exposure Limits/Guidelines Refer to the occupational exposure limits / guidelines for the individual product components. Ethanol ( ) Glycerin ( ) Exposure Limits/Guidelines Result ACGIH Canada Quebec NIOSH OSHA TWAs Not established 1000 ppm TWAEV; 1880 mg/m3 TWAEV 1000 ppm TWA; 1900 mg/m3 TWA 1000 ppm TWA; 1900 mg/m3 TWA STELs 1000 ppm STEL Not established Not established Not established TWAs Not established 10 mg/m3 TWAEV (mist) Not established 15 mg/m3 TWA (mist, total particulate); 5 mg/m3 TWA (mist, respirable fraction) Exposure Control Notations ACGIH Ethanol ( ): Carcinogens: (A3 Confirmed Animal Carcinogen with Unknown Relevance to Humans) Exposure controls Engineering Measures/Controls Good general ventilation should be used. Ventilation rates should be matched to conditions. If applicable, use process enclosures, local exhaust ventilation, or other engineering controls to maintain airborne levels below recommended exposure limits. If exposure limits have not been established, maintain airborne levels to an acceptable level. Personal Protective Equipment Respiratory No respiratory protection required during normal handling. Eye/Face Avoid contact with the eye. No special controls or personal protection required under conditions of intended use. In the event of a bulk spill, appropriate eye protection should be worn. Hands Gloves are not required under normal handling conditions. Skin/Body No special personal protection required under conditions of intended use. In the event of a bulk spill, wear appropriate protective clothing. Environmental Exposure Controls Section 9 Physical and Chemical Properties Information on Physical and Chemical Properties Material Description Physical Form Liquid Color Clear Colorless. Odor Camphor like Odor Threshold No data available General Properties Boiling Point No data available Melting Point Not relevant Page 4 of 9

5 Decomposition Temperature No data available ph No data available Specific Gravity/Relative Density No data available Water Solubility No data available Viscosity No data available Volatility Vapor Pressure No data available Vapor Density No data available Evaporation Rate No data available Flammability Flash Point Not relevant UEL Not relevant LEL Not relevant Autoignition Not relevant Environmental Octanol/Water Partition coefficient No data available Section 10: Stability and Reactivity Reactivity Chemical stability Possibility of hazardous reactions Conditions to avoid Incompatible materials No dangerous reactions known. Stable under normal temperatures and pressures. None. Hazardous decomposition products None expected. Section 11 Toxicological Information Information on toxicological effects Other Material Information Toxicological information refers to raw materials only. Concentrations and toxicological effects are substantially reduced in the product. Components Pramoxine Hydrochloride (1%) Zinc acetate, dihydrate (0.1%) Acute Toxicity: Ingestion/Oral Mouse LD mg/kg Acute Toxicity: Ingestion/Oral Rat LD mg/kg; Sense Organs and Special Senses:Eye:Miosis (pupillary constriction); Vascular:BP elevation not characterized in autonomic section; Nutritional and Gross Metabolic:Gross Metabolite Changes:Weight loss or decreased weight gain; Irritation: Eye Rabbit 20 mg 24 Hour(s) Moderate irritation; Skin Rabbit 500 mg 24 Hour(s) Mild irritation GHS Properties Acute toxicity Classification Classification criteria not met Aspiration Hazard Carcinogenicity Classification criteria not met Classification criteria not met Page 5 of 9

6 Germ Cell Mutagenicity Skin corrosion/irritation Skin sensitization STOT RE STOT SE Toxicity for Reproduction Respiratory sensitization Serious eye damage/irritation Classification criteria not met Classification criteria not met Classification criteria not met Classification criteria not met Classification criteria not met Classification criteria not met Classification criteria not met Eye Mild Irritation 2B Potential Health Effects Inhalation Acute (Immediate) Under normal conditions of use, no health effects are expected. Chronic (Delayed) Under normal conditions of use, no health effects are expected. Skin Acute (Immediate) Under normal conditions of use, no health effects are expected. Chronic (Delayed) Under normal conditions of use, no health effects are expected. Eye Acute (Immediate) Causes mild eye irritation with direct contact to eye. Chronic (Delayed) Under normal conditions of use, no health effects are expected. Ingestion Acute (Immediate) Under normal conditions of use, no health effects are expected. Chronic (Delayed) Under normal conditions of use, no health effects are expected. Carcinogenic Effects CAS IARC NTP Ethanol Group 1 Carcinogenic Evidence of Carcinogenicity Section 12 Ecological Information Toxicity Persistence and degradability Bioaccumulative potential Mobility in Soil Other adverse effects This material has not been tested for environmental effects. Section 13 Disposal Considerations Waste treatment methods Product waste Waste characterizations and compliance with applicable laws are the responsibility Page 6 of 9

7 solely of the waste generator. Packaging waste Dispose of content and/or container in accordance with local, regional, national, and/or international regulations. Section 14 Transport Information UN number UN proper shipping name Transport hazard class (es) Packing group Environmental hazards DOT NDA Not regulated NDA NDA NDA TDG NDA Not regulated NDA NDA NDA IMO/IMDG NDA Not regulated NDA NDA NDA IATA/ICAO NDA Not regulated NDA NDA NDA Special precautions for user Transport in bulk according to Annex II of MARPOL 73/78 and the IBC Code Section 15 Regulatory Information Safety, health and environmental regulations/legislation specific for the substance or mixture SARA Hazard Classifications Inventory Component CAS Canada DSL EU EINECS TSCA Camphor Yes Yes Yes Ethanol Yes Yes Yes Glycerin Yes Yes Yes Hydroxypropyl methylcellulose Pramoxine Hydrochloride Zinc acetate, dihydrate Yes No Yes Yes Yes No Yes No No Canada Labor Canada List of Prohibited and Restricted Cosmetic Ingredients (The Cosmetic Ingredient Hotlist) Ethanol Not Listed Restricted (Manufacturers of oral and leave on products containing Glycerin must ensure the raw material used is within the specifications of Glycerin an accepted pharmacopoeia with respect to Diethylene glycol (DEG) impurities (e.g. Glycerin Official Monograph in the most current edition of the Page 7 of 9

8 USP)) Canada WHMIS Classifications of Substances Uncontrolled product Zinc acetate, dihydrate according to WHMIS classification criteria Uncontrolled product Hydroxypropyl methylcellulose according to WHMIS classification criteria Ethanol B2, D2B Uncontrolled product Glycerin according to WHMIS classification criteria Camphor B4 Canada WHMIS Ingredient Disclosure List Ethanol % Camphor % Europe Other EU CLP (1272/2008) Annex VI Table 3.2 Classification Ethanol F; R11 EU CLP (1272/2008) Annex VI Table 3.2 Labelling Ethanol F R:11 S:(2) 7 16 EU CLP (1272/2008) Annex VI Table 3.2 Safety Phrases Ethanol S:(2) 7 16 United States California Page 8 of 9

9 Environment U.S. California Proposition 65 Carcinogens List Ethanol carcinogen, initial date 4/29/ (in alcoholic beverages) U.S. California Proposition 65 Developmental Toxicity developmental toxicity, initial Ethanol date 10/1/87 (in alcoholic beverages) U.S. California Proposition 65 Reproductive Toxicity Female Ethanol Not Listed U.S. California Proposition 65 Reproductive Toxicity Male Ethanol Not Listed Section 16 Other Information Last Revision Date 04/June/2015 Preparation Date 04/June/2015 Disclaimer/Statement of Liability To the best of our knowledge, the information contained herein is accurate. However, neither Valeant Pharmaceuticals International, Inc. nor any of its subsidiaries assumes any liability whatsoever for the accuracy or completeness of the information contained herein. Final determination of suitability of any material is the sole responsibility of the user. All materials may present unknown hazards and should be used with caution. Although certain hazards are described herein, we cannot guarantee that these are the only hazards that exist. NO WARRANTY, EXPRESS OR IMPLIED, OF MERCHANTABILITY, FITNESS OR OTHERWISE IS MADE. In no event shall Valeant Pharmaceuticals International, Inc. or any of its subsidiaries be liable for any special, incidental or consequential damages. Page 9 of 9