ANTIBACTERIAL GOLD- benzalkonium chloride soap
Kareway Product, 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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Pure-Aid Antibacterial Soap Gold

Active Ingredient

Benzalkonium Chloride 0.1%

Purpose

Antibacterial

Use

For washing to decrease bacteria on the skin

Warnings

For external use only

Avoid contact with eyes. In case of eye contact, flush with water.
Stop use and ask a doctor if irritation and redness develops.

Keep out of reach of children.

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

Directions

Wet bar with water
Lather vigorously and wash skin
Rinse and dry thoroghly

Inactive Ingredient

butylated hydroxytoluene, etidronate tetrasodium, fragrance, glycerine, orange HO, PEG-6 methyl ether, pentasodium pentetate, sodium chloride, sodium laureth-5 sulfate, sodium palm kernelate, sodium palmate, sorbitol, titanium dioxide, water

Package label

carton

ANTIBACTERIAL GOLD
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:67510-0116
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.1 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
PALMITIC ACID (UNII: 2V16EO95H1)
PEG-6 METHYL ETHER (UNII: WXH089JZ5E)
PENTASODIUM PENTETATE (UNII: 961TOZ5L7T)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM PALMITATE (UNII: JQ43KP6296)
SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)
SORBITOL (UNII: 506T60A25R)
ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4)
WATER (UNII: 059QF0KO0R)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:67510-0116-3	3 in 1 CELLO PACK	07/10/2020
1		100 g in 1 BOX; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	07/10/2020

Labeler - Kareway Product, Inc. (121840057)