GUARD ALCOHOL-FREE HAND SANITIZER- benzalkonium chloride gel

Guard Alcohol-Free Hand Sanitizer by

Drug Labeling and Warnings

Guard Alcohol-Free Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Apollo Health and Beauty Care Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Benzalkonium chloride 0.13%

Purpose

Antiseptic

Uses

to help reduce bacteria on the skin. For use when soap and water are not available.

Warnings

For external use only

When using this product

avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Do not use 

• on children less than 2 months of age
• on open skin wounds

Stop use and ask a doctor if

irritation develops

Keep out of reach of children.

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

Directions

• put enough product in your palm to cover hands, rub hands together for at least 30 seconds. Allow to dry.
• Children under 6 years should be supervised when using this product.

Inactive ingredients

Water (Aqua), Hydroxyethylcellulose, Tetrasodium EDTA, Citric Acid, Sodium Hydroxide, DMDM Hydantoin.

Questions?

1-866-695-3030

Label copy

INGREDIENTS AND APPEARANCE

GUARD ALCOHOL-FREE HAND SANITIZER 
benzalkonium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63148-514
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HYDROXYETHYL CELLULOSE (5000 CPS AT 1%) (UNII: X70SE62ZAR)
EDETATE SODIUM (UNII: MP1J8420LU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
DMDM HYDANTOIN (UNII: BYR0546TOW)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63148-514-02	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/17/2020
2	NDC: 63148-514-08	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/17/2020
3	NDC: 63148-514-32	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/17/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	04/17/2020

Labeler - Apollo Health and Beauty Care Inc. (201901209)

Registrant - Apollo Health and Beauty Care Inc. (201901209)

Establishment
Name	Address	ID/FEI	Business Operations
Apollo Health and Beauty Care Inc.		201901209	manufacture(63148-514)