Label: ISOPROPYL ALCOHOL solution
- NDC Code(s): 0168-0907-60
- Packager: Fougera Pharmaceuticals 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.
Updated April 28, 2020
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This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.
The hand sanitizer is manufactured using only USP grade ingredients in the preparation of the product, consistent with World Health Organization (WHO) recommendations.
The firm does not add other active or inactive ingredients.
- Active ingredient(s)
- Do Not Use
- Keep Out of Reach of Children
- Other Information
- Inactive Ingredients
- Package/Label Principal Display Panel - 60mL Bottle
INGREDIENTS AND APPEARANCE
isopropyl alcohol solution
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0168-0907 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 75 mL in 60 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) HYDROGEN PEROXIDE (UNII: BBX060AN9V) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0168-0907-60 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/15/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/15/2020 Labeler - Fougera Pharmaceuticals Inc. (043838424) Establishment Name Address ID/FEI Business Operations Fougera Pharmaceuticals Inc. 174491316 MANUFACTURE(0168-0907)