Label: ANTIBACTERIAL HAND SANITIZER gel
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Contains inactivated NDC Code(s)
NDC Code(s): 75129-002-01, 75129-002-02, 75129-002-03, 75129-002-04 - Packager: Shanghai Rayshine ENVI-TECH Developing CO., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated April 18, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- 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
ANTIBACTERIAL HAND SANITIZER
antibacterial hand sanitizer gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75129-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLUTARAL (UNII: T3C89M417N) (GLUTARAL - UNII:T3C89M417N) GLUTARAL 0.3 g in 100 mL CARBONIC ANHYDRASE 1 (UNII: 31F7ZV0E20) (CARBONIC ANHYDRASE 1 - UNII:31F7ZV0E20) CARBONIC ANHYDRASE 1 3.8 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75129-002-01 300 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/18/2020 2 NDC:75129-002-02 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/18/2020 3 NDC:75129-002-03 3785 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/18/2020 4 NDC:75129-002-04 5000 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/18/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 04/18/2020 Labeler - Shanghai Rayshine ENVI-TECH Developing CO., Ltd. (420836386) Registrant - Shanghai Rayshine ENVI-TECH Developing CO., Ltd. (420836386) Establishment Name Address ID/FEI Business Operations Shanghai Rayshine ENVI-TECH Developing CO., Ltd. 420836386 manufacture(75129-002)