Label: HAND SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 78389-003-99 - Packager: ABSOLUTE MARKETING, 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 5, 2020
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- Official Label (Printer Friendly)
- Active Ingredient(s)
- Purpose
- Use
- Warnings
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Package Label - Principal Display Panel
- PDP 78389-003-99
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INGREDIENTS AND APPEARANCE
HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78389-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength TRIETHANOLAMINE DODECYLBENZENESULFONATE (UNII: 8HM7ZD48HN) 0.1 mL in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 1 mL in 100 mL CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L) 0.25 mL in 100 mL WATER (UNII: 059QF0KO0R) 28.65 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78389-003-99 3780 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/12/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 06/12/2020 Labeler - ABSOLUTE MARKETING, INC. (117483207) Registrant - ABSOLUTE MARKETING, INC. (117483207) Establishment Name Address ID/FEI Business Operations Beaming White LLC 019910700 manufacture(78389-003)