Country: United States
Language: English
Source: NLM (National Library of Medicine)
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Pro Skin Solutions, Inc. DBA Active Cosmetics Manufacturing
TOPICAL
OTC DRUG
Hand sanitizer to help reduce bacteria that could potentially cause disease. For use when soap and water are not available.
OTC monograph not final
BEAUTY BY EARTH HAND SANITIZER- ALCOHOL GEL PRO SKIN SOLUTIONS, INC. DBA ACTIVE COSMETICS MANUFACTURING _Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may_ _be marketed if they comply with applicable regulations and policies. FDA has not_ _evaluated whether this product complies._ ---------- BEAUTY BY EARTH HAND SANITIZER _DRUG FACTS_ _ACTIVE INGREDIENTS_ Alcohol Denat.62% _PURPOSE_ Antiseptic _USES_ Hand sanitizer to help reduce bacteria that could potentially cause disease. For use when soap and water are not available. _WARNINGS_ FOR EXTERNAL USE ONLY. FLAMMABLE. KEEP AWAY FROM HEAT OR FLAME. DO NOT USE: On children under 2 months old On open wounds WHEN USING THIS PRODUCT keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water. STOP USE AND ASK A DOCTOR if irritation or rash appears. This may be a sign of a serious condition. KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact Poison Control Center right away. _DIRECTIONS_ Place enough product on your hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing. OTHER INFORMATION Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F) _INACTIVE INGREDIENTS_ Water (Aqua), Glycerin (Vegetable), Organic Aloe Barbadensis (Aloe Vera) Leaf Juice, Hydroxypropyl Guar, Panthenol, Organic Lavandula Officinalis (Lavender) Flower Essential oil, Organic Mentha piperita (Peppermint) Essential Oil, Citric Acid PACKAGE LABELING : 473.18ML PACKAGE LABELING : 340ML BEAUTY BY EARTH HAND SANITIZER alcohol gel PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:15464-0001 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.62 mL in 1 mL INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) ALOE VERA L Read the complete document