Label: ADVANCED HAND SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 75311-000-01, 75311-000-02, 75311-000-03 - Packager: UNISOURCES GROUP LLC
- 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 June 24, 2020
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Uses
- Warnings
- Directions
- Other information
- Inactive ingredients
- Package Labeling: 59mL
- Package Labeling: 236mL
- Package Labeling: 295mL
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INGREDIENTS AND APPEARANCE
ADVANCED HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75311-000 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.72 mL in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) ALOE VERA LEAF (UNII: ZY81Z83H0X) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75311-000-01 59 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/31/2020 2 NDC:75311-000-02 236 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/31/2020 3 NDC:75311-000-03 295 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/31/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 05/31/2020 Labeler - UNISOURCES GROUP LLC (117474227) Establishment Name Address ID/FEI Business Operations Hangzhou Huiji Biotechnology Co., Ltd. 526893497 manufacture(75311-000)