HAND SANITIZER- alcohol gel
AEROQUEST, 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

Ethyl Alcohol 70% v/v.

Uses

antiseptic skin cleanser
antibacterial cleanser
kills harmful bacteria and germs

Warnings

For external use only.

Flammability warning: Keep away from open flame and sources of heat.

When using this product avoid contact with eyes. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation develops.

Keep out of reach of children. If swallowed, call a poison control center or get medical help right away.

Directions

Adults and children over 2 years: For occasional and personal domestic use.
Supervise children when they use this product.
Rub thoroughty into hands for at least 30 seconds. Allow to dry.

Inactive ingredients

Aqua, Carboxymethyl cellulose, tert - butyl alcohol, denatonium benzoate

Product Label

image description

HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:79352-001
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
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
DENATONIUM BENZOATE ANHYDROUS (UNII: M5BA6GAF1O)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:79352-001-01	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2020
2	NDC:79352-001-02	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2020
3	NDC:79352-001-03	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2020
4	NDC:79352-001-04	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2020
5	NDC:79352-001-05	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2020
6	NDC:79352-001-06	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	06/01/2020

Labeler - AEROQUEST, INC (883142077)