Label: HAND SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 62685-119-01, 62685-119-02 - Packager: Tropical Degil Cosmetics Industries Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated May 13, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient(s)
- Purpose
- Use
- Warnings
- Do not use
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62685-119 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) GLYCERIN (UNII: PDC6A3C0OX) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) WATER (UNII: 059QF0KO0R) TROLAMINE (UNII: 9O3K93S3TK) DENATONIUM BENZOATE (UNII: 4YK5Z54AT2) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62685-119-01 300 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 2 NDC:62685-119-02 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/30/2020 Labeler - Tropical Degil Cosmetics Industries Ltd. (600437230) Establishment Name Address ID/FEI Business Operations Tropical Degil Cosmetics Industries 600437230 manufacture(62685-119)