Country: United States
Language: English
Source: NLM (National Library of Medicine)
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Schreiber Foods International, Inc.
TOPICAL
OTC DRUG
Antiseptic 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 if irritation or rash occurs. These may be signs of a serious condition.
OTC monograph not final
HAND WIPES TOWELETTES- ALCOHOL CLOTH SCHREIBER FOODS INTERNATIONAL, 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._ ---------- ANTISEPTIC ALCOHOL WIPES _DRUG FACTS_ _ACTIVE INGREDIENT_ Alcohol 80% v/v _PURPOSE_ Antiseptic _USES_ 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. Incase 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. KEEP OUT OF REACH OF CHILDREN. If swalled, get medical help or contact a PoisonControl Center right away. _DIRECTIONS_ Wipe hands;discard _OTHER INSTRUCTIONS_ Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F) _INACTIVE INGREDIENTS_ Water, Fragrance FIVESTAR (TM) HAND SANI-WIPE HAND SANITIZER 80& ALCOHOL CONTENT KILLS 99.9% OF GERMS ITEM: 91205 Product of Turkey Distributed by: Schreiber Foods International, Inc. Ramsey NJ 07466 FiveStarPPE.com or call 1-800-631-7070 LABEL - ANTISEPTIC TOWLETTE HAND WIPES TOWELETTES alcohol cloth PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:76 758 -9 12 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 8 0 mL in 10 0 mL Schreiber Foods International, Inc. INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH WATER (UNII: 0 59 QF0 KO0 R) PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:76 758 -9 12-10 10 0 0 in 1 CARTON 0 7/27/20 20 1 2.5 mL in 1 PACKET; Type 0 : Read the complete document