Label: HAND SANITIZER- ethyl alcohol gel
- NDC Code(s): 78602-002-01
- Packager: Three Square Market, Inc
- 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 1, 2020
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
HAND SANITIZER
ethyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78602-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 62 mL in 100 mL Inactive Ingredients Ingredient Name Strength MALTODEXTRIN (UNII: 7CVR7L4A2D) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) GLYCERIN (UNII: PDC6A3C0OX) CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78602-002-01 59 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/03/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 06/03/2020 Labeler - Three Square Market, Inc (117117771)