Label: ANTIBACTERIAL HAND SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 90121-002-15, 90121-002-30, 90121-002-59 - Packager: Sweda Company 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 August 31, 2020
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredients
- Uses:
- Warnings:
- Directions:
- Other information:
- Inactive Ingredients:
- Package Labeling:15ml
- Package Labeling:30ml
- Package Labeling:59ml
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INGREDIENTS AND APPEARANCE
ANTIBACTERIAL HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:90121-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.62 mL in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) TROLAMINE (UNII: 9O3K93S3TK) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:90121-002-15 15 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/30/2020 2 NDC:90121-002-30 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/30/2020 3 NDC:90121-002-59 59 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/30/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 07/30/2020 Labeler - Sweda Company LLC (081729899)
