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 Hand Sanitizer

Active ingredient

Ethyl Alcohol 70% v/v

Uses

Hand sanitizer to reduce microorganisms on the skin.

Use this product when soap and water are not available.

Warnings

For external use only. FLAMMABLE. This product contains ethyl alcohol.

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.

Place a palmful (5 grams) of product in one hand.

Spread on both handsand rub into the skin until dry (1-2 min).

Inactive Ingredients

Aloe Barbadensis Leaf Juice, D&C Green #5, Fragrance, PEG-10 Acrylate/Perfluorohexylethyl Acrylate Copolymer, Perfluorohexylethyl Alcohol, Propylene Glycol, Water

Purpose

Antiseptic

Keep out of reach of children

Keep out of the reach of children

Label

Foaming Hand Sanitizer

INDIVIDUAL FREE AND CLEAR FOAMING ANTIBACTERIAL SKIN CLEANSER
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:79258-795
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DEHYDRATED ALCOHOL (UNII: 3K9958V90M) (DEHYDRATED ALCOHOL - UNII:3K9958V90M)	DEHYDRATED ALCOHOL	0.7 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
PEG-10 ACRYLATE/PERFLUOROHEXYLETHYL ACRYLATE COPOLYMER (UNII: D76Z87928N)
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)
2-(PERFLUOROHEXYL)ETHANOL (UNII: G2R5YO5N3V)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:79258-795-29	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(79258-795) , label(79258-795) , analysis(79258-795) , pack(79258-795)