P.o.v. Light Moisturizing Antibacterial Hand (Benzalkonium Chloride) Soap [Apollo Health And Beauty Care Inc.] -

P.O.V. LIGHT MOISTURIZING ANTIBACTERIAL HAND (BENZALKONIUM CHLORIDE) SOAP [APOLLO HEALTH AND BEAUTY CARE INC.]
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NDC	63148-199-08, 63148-199-56
Set ID	b66d9567-90a4-4263-b7dd-a6d1959d2839
Category	HUMAN OTC DRUG LABEL
Packager	Apollo Health and Beauty Care Inc.
Generic Name
Product Class
Product Number
Application Number	PART333E

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Active ingredient

Benzalkonium Chloride 0.13%

Purpose

Antibacterial
Uses

helps eliminate bacteria on hands.
Warnings

For external use only.

When using this product

avoid contact with eyes. In case of contact, rinse thoroughly with water.

Stop use and ask a doctor if

irritation or redness develops and lasts.

Keep out of reach of children.

In cast of accidental ingestion, get medical help or contact a Poison Control Center immediately.
Directions
- apply onto dry hadns
- lather and rinse thoroughly.
Other information

Store at room temperature.
Inactive ingredients

Water (Aqua), Lauramidopropylamine Oxide, Glycerin, Cetrimonium Chloride, Sodium Chloride, Cocamide MEA, PEG-120 Methyl Glucose Dioleate, Fragrance (Parfum), Citric Acid, Tetrasodium EDTA, Sodium Sulfate, Methylchloroisothiazolinone, Methylisothiazolinone, Red 40 (CI 16035), Yellow 5 (CI 19140), Red 33 (CI 17200).
Questions or comments?

1-866-695-3030
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INGREDIENTS AND APPEARANCE

P.O.V. LIGHT MOISTURIZING ANTIBACTERIAL HAND
benzalkonium chloride soap

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)
LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)
GLYCERIN (UNII: PDC6A3C0OX)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE SODIUM (UNII: MP1J8420LU)
SODIUM SULFATE (UNII: 0YPR65R21J)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63148-199-08	222 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/10/2017
2	NDC:63148-199-56	1656 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/10/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	11/10/2017

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(63148-199)

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