NATURAL CONCEPTS ALCOHOL-FREE HAND SANITIZER- benzalkonium chloride gel
Apollo Health and Beauty Care 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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Drug Facts

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 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 or comments?

1-866-695-3030

Label copy

image of the label

NATURAL CONCEPTS ALCOHOL-FREE HAND SANITIZER
benzalkonium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63148-512
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
HYPROMELLOSES (UNII: 3NXW29V3WO)
EDETATE SODIUM (UNII: MP1J8420LU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
DMDM HYDANTOIN (UNII: BYR0546TOW)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63148-512-09	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/14/2020
2	NDC:63148-512-03	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/14/2020
3	NDC:63148-512-33	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/14/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	04/14/2020

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

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

Name	Address	ID/FEI	Business Operations
Establishment
Apollo Health and Beauty Care Inc.		201901209	manufacture(63148-512)