80 ETHYL ALCOHOL ANTISEPTIC HAND SANITIZER- alcohol liquid
SCHEVARAN LABORATORIES PRIVATE LIMITED

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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80% Ethyl Alcohol Antiseptic Hand Sanitizer

Drug Facts

Active ingredient

Ethyl alcohol 80%

Purpose

Antiseptic

Use

for hand washing to decrease bacteria on the skin

Warnings

For external use only

Flammable, keep away from fire or flame.

Do not use

in the eyes

Stop use and ask a doctor if

Irritation and redness develop
Condition persists for more than 72 hours

Keep out of reach of children.

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

Directions:

wet hands thoroughly with product and allow to dry without wiping.

Inactive ingredients

Hydrogen peroxide, glycerin, FD&C Blue No. 1, fragrance

Questions? :

+1-716-430-3572

Package Labeling:

Label

80 ETHYL ALCOHOL ANTISEPTIC HAND SANITIZER
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82444-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
GLYCERIN (UNII: PDC6A3C0OX)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:82444-001-00	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/30/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	06/30/2022

Labeler - SCHEVARAN LABORATORIES PRIVATE LIMITED (650656770)