P.O.V. Antibacterial Foaming Hand: Package Insert and Label Information

P.O.V. ANTIBACTERIAL FOAMING HAND- benzalkonium chloride soap
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.

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

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P.O.V. ANTIBACTERIAL FOAMING HAND
benzalkonium chloride soap
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63148-197
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 1.3 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
COCAMIDOPROPYL BETAINE
POLYSORBATE 20
GLYCERIN
DECYL GLUCOSIDE
HYDROXYETHYL CELLULOSE (5000 CPS AT 1%)
ALOE VERA LEAF
GREEN TEA LEAF
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW)
EDETATE SODIUM
SODIUM CITRATE
CITRIC ACID MONOHYDRATE
SULISOBENZONE
METHYLCHLOROISOTHIAZOLINONE
METHYLISOTHIAZOLINONE
FD&C YELLOW NO. 5
D&C RED NO. 33
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63148-197-08 222 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 11/10/2017
Labeler — Apollo Health and Beauty Care Inc. (201901209)
Registrant — Apollo Health and Beauty Care Inc. (201901209)
Establishment
Name Address ID/FEI Operations
Apollo Health and Beauty Care Inc. 201901209 manufacture (63148-197)

Revised: 11/2017 Apollo Health and Beauty Care Inc.

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