INDIVIDUAL ANTIBACTERIALLOTION SKIN CLEANSER- chloroxylenol 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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Individual Antibacterial Lotion Skin Cleanser

Active ingredient

Chloroxylenol 0.375% 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

Cocamidopropyl Betaine, Coco MIPA, D&C Green 5, Ethylene Glycol Phenyl Ether, Fragrance, FD&C Yellow 5, Glycerin, Glycol Distearate, Lauramide MIPA, Methylchloroisothiazolinone, Methylisothiazolinone, Propylene Glycol, Sodium Chloride, Sodium Hydroxide, Sodium Laureth Sulfate, Sodium Lauryl Sulfate, Water.

Purpose

Antibacterial

Keep out of reach of children

Keep out of the reach of children

Label

Individual Antibacterial Lotion Skin Cleanser

INDIVIDUAL ANTIBACTERIALLOTION SKIN CLEANSER 
chloroxylenol soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79258-141
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL3.75 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
LAURIC ISOPROPANOLAMIDE (UNII: 82DUX3RRVU)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ETHYL ACETOACETATE (UNII: IZP61H3TB1)  
DIMETHYL BENZYL CARBINYL ACETATE (UNII: 6Y9488RL8H)  
GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
BENZYL BENZOATE (UNII: N863NB338G)  
MAGNESIUM NITRATE (UNII: 77CBG3UN78)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
CHLOROACETIC ACID (UNII: 5GD84Y125G)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
ETHYL METHYLPHENYLGLYCIDATE (UNII: UD51D5KR4A)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
WATER (UNII: 059QF0KO0R)  
SODIUM FERROCYANIDE (UNII: 5HT6X21AID)  
DIOXANE (UNII: J8A3S10O7S)  
ETHYL BUTYRATE (UNII: UFD2LZ005D)  
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
IONONE (UNII: QP734LIN1K)  
ETHYLENE OXIDE (UNII: JJH7GNN18P)  
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
CALCIUM SILICATE (UNII: S4255P4G5M)  
METHYL ALCOHOL (UNII: Y4S76JWI15)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
GLYCERIN (UNII: PDC6A3C0OX)  
LAURIC DIETHANOLAMIDE (UNII: I29I2VHG38)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
.GAMMA.-DECALACTONE (UNII: 7HLS05KP9O)  
METHYL ANTHRANILATE (UNII: 981I0C1E5W)  
SODIUM ALUMINIUM SILICATE (UNII: 058TS43PSM)  
MYRCENE (UNII: 3M39CZS25B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79258-141-043785 mL in 1 JUG; Type 0: Not a Combination Product03/02/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/02/2022
Labeler - Brady Industries Inc. (034932657)
Registrant - Betco Corporation (005050158)
Establishment
NameAddressID/FEIBusiness Operations
Betco Corporation005050158manufacture(79258-141) , label(79258-141) , analysis(79258-141) , pack(79258-141)

Revised: 3/2022
Document Id: d9681642-2377-93f3-e053-2a95a90aa5c0
Set id: d9681642-2376-93f3-e053-2a95a90aa5c0
Version: 1
Effective Time: 20220302
 
Brady Industries Inc.