Country: United States
Language: English
Source: NLM (National Library of Medicine)
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Medisys USA, Inc.
TOPICAL
OTC DRUG
Antiseptic, Hand Sanitizer Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available. - in children less than 2 months of age - on open skin wounds Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
OTC monograph not final
75% ETHYL ALCOHOL GEL SANITIZER- ALCOHOL LIQUID MEDISYS USA, INC. _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._ ---------- 75% ETHYL ALCOHOL GEL ACTIVE INGREDIENT(S) Alcohol 75% v/v. Purpose: Antiseptic PURPOS E Antiseptic, Hand Sanitizer US E Hand Sanitizer to help reduce bacteria that potentially can 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 in children less than 2 months of age on open skin 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 occurs. These may be signs of a serious condition. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. DIRECTIONS Place enough product on 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, Acrylates Copolymer, Fragrance, Aminoethyl Propanol PACKAGE LABEL - PRINCIPAL DISPLAY PANEL 59 mL NDC: 78364-500-02 236.5 mL NDC: 78364-500-08 Medisys USA, Inc. 75% ETHYL ALCOHOL GEL SANITIZER alcohol liquid PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:78 36 4-50 0 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH ALCO HO L (UNII: 3K9 9 58 V9 0 M) (ALCOHOL - UNII:3K9 9 58 V9 0 M) ALCOHOL 75 mL in 10 0 mL INACTIVE INGREDIENTS INGREDIENT NAME S Read the complete document