FOODAROM HAND SANITIZER ETHANOL 70%- alcohol liquid 
Foodarom USA Inc.

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.

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Active Ingredient

Alcohol 71.28% v/v.

Purpose

Antiseptic

Uses

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

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 wounds

When 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. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

ethyl lactate, glycerin, purified water

Package Label - Principal Display Panel

Label

FOODAROM HAND SANITIZER ETHANOL 70% 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78968-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL71.28 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
ETHYL LACTATE (UNII: F3P750VW8I)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78968-001-0122094 mL in 1 CONTAINER; Type 0: Not a Combination Product06/23/2020
2NDC:78968-001-02198860 mL in 1 CONTAINER; Type 0: Not a Combination Product06/23/2020
3NDC:78968-001-03939066 mL in 1 CONTAINER; Type 0: Not a Combination Product06/23/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/23/2020
Labeler - Foodarom USA Inc. (960317282)

Revised: 6/2020
Document Id: e3802301-5db5-4dc6-8aa3-86ca619c7814
Set id: 536a0866-f530-487e-8838-2f87630bf44c
Version: 1
Effective Time: 20200623
 
Foodarom USA Inc.