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

P.O.V. ANTIBACTERIAL FOAMING HAND (BENZALKONIUM CHLORIDE) SOAP [APOLLO HEALTH AND BEAUTY CARE INC.]
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NDC	63148-197-08
Set ID	3e594ee5-3900-476f-87aa-91b046dcab12
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 case of accidental ingestion, get medical help or contact a Poison Control Center immediately.
Directions

Pump onto wet hands, rub into a rich foamy lather and rinse clean.
Other information

store at room temperature.
Inactive ingredients

Water (Aqua), Cocamidopropyl Betaine, Polysorbate 20, Fragrance (Parfum), Glyceirn, Decyl Glucoside, Hydroxyethylcellulose, Aloe Barbadensis Leaf Juice, Camellia Sinensis Leaf Extract, Polyquaternium-7, Tetrasodium EDTA, Sodium Citrate, Citric Acid, Benzophenone-4, Methylchloroisothiazolinone, Methylisothiazolinone, Yellow 5 (CI 19140), Red 33 (CI 17200).
Label Copy

INGREDIENTS AND APPEARANCE

P.O.V. ANTIBACTERIAL FOAMING 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)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
GLYCERIN (UNII: PDC6A3C0OX)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
HYDROXYETHYL CELLULOSE (5000 CPS AT 1%) (UNII: X70SE62ZAR)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)
EDETATE SODIUM (UNII: MP1J8420LU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SULISOBENZONE (UNII: 1W6L629B4K)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63148-197-08	222 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(63148-197)

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