Label: SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 69394-002-01, 69394-002-02 - Packager: AAkron Rule Corporation
- 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 July 25, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Use
- Warnings
- Do not use
- WHEN USING
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69394-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 80 mL in 100 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) CETEARETH-5 (UNII: 2AAD28764Q) CYCLOHEXANE (UNII: 48K5MKG32S) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69394-002-01 29 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/28/2020 2 NDC:69394-002-02 89 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/28/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 09/28/2020 Labeler - AAkron Rule Corporation (002434389)
