INDIVIDUAL FREE AND CLEAR FOAMING ANTIBACTERIAL SKIN CLEANSER- benzalkonium chloride soap
Brady Industries 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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Foaming Antibacterial Skin Cleanser

Active ingredient

Benzalkonium Chloride 0.13% w/w

Uses

Antibacterial skin cleanser

Effective in destroying harful bacteria to prevent antibacterial cleansing

Warnings

For external use only.

When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs.

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Read entire label before using this product.

Apply 5 milliliters (teaspoonful) or palmful to hands and forearms.

Scrub thoroughly for 20 seconds and rinse with clean water.

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Citric Acid, FD&C Red 40, FD&C Yellow 5, Fragrance, Glycerin, Laurmine Oxide, Methylchloroisothiazolinone, Methylisothiazolinone, Tetrasodium Glutamate Diacetate, Water

Purpose

Antibacterial

Keep out of reach of children

Keep out of the reach of children

Label

Foaming Antibacterial Skin Cleanser

INDIVIDUAL FREE AND CLEAR FOAMING ANTIBACTERIAL SKIN CLEANSER
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:79258-751
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
GLYCERIN (UNII: PDC6A3C0OX)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
FD&C RED NO. 40 (UNII: WZB9127XOA)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
WATER (UNII: 059QF0KO0R)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:79258-751-29	1000 mL in 1 BAG; Type 0: Not a Combination Product	03/02/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	03/02/2022

Labeler - Brady Industries Inc. (034932657)

Registrant - Betco Corporation (005050158)

Name	Address	ID/FEI	Business Operations
Establishment
Betco Corporation		005050158	manufacture(79258-751) , label(79258-751) , analysis(79258-751) , pack(79258-751)