Country: United States
Language: English
Source: NLM (National Library of Medicine)
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Shandong Vianor Healthy Science Co., Ltd.
TOPICAL
OTC DRUG
Antimicrobial Hand sanitizer to help reduce bacteria on the skin. Do not use on children less than 2 months of age. Do not use on open skin wounds. If skin irritation occurs, discontinue use. Consult a doctor if rash persit.
OTC monograph not final
HAND SANITIZER- 65% ALCOHOL GEL SHANDONG VIANOR HEALTHY SCIENCE CO., LTD. _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._ ---------- VIANOR, HAND SANITIZER, 65% ALCOHOL, GEL, 60ML ACTIVE INGREDIENT(S) Alcohol 65% v/v. Purpose: Antimicrobial PURPOS E Antimicrobial US E Hand sanitizer to help reduce bacteria on the skin. WARNINGS Flammable. Keep product away from open flames. For external use only. DO NOT USE Do not use on children less than 2 months of age. Do not use on open skin wounds. When using this product, avoid contact with eyes and broken skin. In case of contact with eyes, rinse immediately with water. If skin irritation occurs, discontinue use. Consult a doctor if rash persit. Keep out of reach of children and superise during use. DIRECTIONS Rua hands throughly with gel and let dry. OTHER INFORMATION Do not strore above 110 /43 . INACTIVE INGREDIENTS Water, VE. PACKAGE LABEL - PRINCIPAL DISPLAY PANEL HAND SANITIZER 65% alcohol gel PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:6 9 9 8 0 -10 1 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY Shandong Vianor Healthy Science Co., Ltd. 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 39 mL in 6 0 mL INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH WATER (UNII: 0 59 QF0 KO0 R) .ALPHA.-TO CO PHERO L, D- (UNII: N9 PR349 0 H9 ) PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:6 9 9 8 0 -10 1- 0 3 6 0 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n Pro duc t 0 5/20 /20 20 MARKETING INFORMATION MARKE TING CATE GORY APPLICATION NUMBE R OR MONOGRAPH CITATION MARKE TING START DATE MARKE TING END DATE OTC mo no graph no t final pa rt333A 0 5/20 /20 20 LABELER - Shandong Vianor Healthy Science Co., Ltd. (554532204) REGISTRANT - A03 Lab of BT S (548009541) Read the complete document