Label: HAND SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 78227-000-01, 78227-000-02, 78227-000-03 - Packager: SOFi Paper Products 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 11, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient
- Use
- Warnings
- Directions
- Other Information
- Inactive Ingredients:
- Package Labeling:78227-000-01
- Package Labeling:78227-000-02
- Package Labeling:78227-000-03
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INGREDIENTS AND APPEARANCE
HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78227-000 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.7 mL in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) TROLAMINE (UNII: 9O3K93S3TK) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) POLYSORBATE 20 (UNII: 7T1F30V5YH) GLYCERIN (UNII: PDC6A3C0OX) ALOE (UNII: V5VD430YW9) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78227-000-01 236 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/25/2020 2 NDC:78227-000-02 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/25/2020 3 NDC:78227-000-03 3785 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 part333E 05/25/2020 Labeler - SOFi Paper Products LLC (117491636)
