Label: 75% ALCOHOL HAND SANITIZER- alcohol gel
- NDC Code(s): 78615-001-01, 78615-001-02, 78615-001-03
- Packager: Narwhal, Inc.
- This is a repackaged label.
- Source NDC Code(s): 74621-010
- 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 February 13, 2023
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
- Directions
- Warnings
- DO NOT USE
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Inactive ingredients
- OTHER SAFETY INFORMATION
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
75% ALCOHOL HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78615-001(NDC:74621-010) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 75 mL in 100 mL Inactive Ingredients Ingredient Name Strength ACRYLIC ACID (UNII: J94PBK7X8S) WATER (UNII: 059QF0KO0R) TROLAMINE (UNII: 9O3K93S3TK) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78615-001-01 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/01/2020 2 NDC:78615-001-02 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/01/2020 3 NDC:78615-001-03 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/31/2020 Labeler - Narwhal, Inc. (102299663) Registrant - Aogrand International Trade Corporation (421353092)
