Label: FOODAROM HAND SANITIZER ETHANOL 70%- alcohol liquid
-
Contains inactivated NDC Code(s)
NDC Code(s): 78968-001-01, 78968-001-02, 78968-001-03 - Packager: Foodarom USA 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 23, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
-
Warnings
For external use only. Flammable. Keep away from heat or flame.
Do not use
• in children less than 2 months of age
• on open skin woundsWhen using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Package Label - Principal Display Panel
-
INGREDIENTS AND APPEARANCE
FOODAROM HAND SANITIZER ETHANOL 70%
alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78968-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 71.28 mL in 100 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) ETHYL LACTATE (UNII: F3P750VW8I) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78968-001-01 22094 mL in 1 CONTAINER; Type 0: Not a Combination Product 06/23/2020 2 NDC:78968-001-02 198860 mL in 1 CONTAINER; Type 0: Not a Combination Product 06/23/2020 3 NDC:78968-001-03 939066 mL in 1 CONTAINER; Type 0: Not a Combination Product 06/23/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 06/23/2020 Labeler - Foodarom USA Inc. (960317282)