70% ALCOHOL HAND SANITZER- alcohol gel
D Zone Imports, Llc

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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70% alcohol hand sanitzer

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease.

Warnings

For external use only. Flammable. Keep away from heat or flame

When using this product

Avoid contact with face, eyes, and broken skin. In case of eye contact, flush with plenty of water and seek medical advice.

Stop use and ask a doctor if

irritation or redness develops

Keep out of reach of children.

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

Directions

Wet hands thoroughly with product and rub into skin until dry.
Children under 6 years of age should be supervised by an adult when using.

Other information

Store at room temperature
May discolor certain fabrics

Inactive ingredients

Deionized Water, Glycerol, Carbopol, Triethanolamine

Package Label - Principal Display Panel

60 mL NDC: 75021-003-01

PDP

70% ALCOHOL HAND SANITZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:75021-003(NDC:56084-020)
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:75021-003-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/18/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	06/18/2020

Labeler - D Zone Imports, Llc (604227103)