INDIVIDUAL ANTIBACTERIALLOTION SKIN CLEANSER- chloroxylenol soap

Individual AntibacterialLotion Skin Cleanser by

Drug Labeling and Warnings

Individual AntibacterialLotion Skin Cleanser by is a Otc medication manufactured, distributed, or labeled by Brady Industries Inc., Betco Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

INDIVIDUAL ANTIBACTERIALLOTION SKIN CLEANSER 
chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79258-141
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	3.75 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79258-141-04	3785 mL in 1 JUG; Type 0: Not a Combination Product	03/02/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/02/2022

Labeler - Brady Industries Inc. (034932657)

Registrant - Betco Corporation (005050158)

Establishment
Name	Address	ID/FEI	Business Operations
Betco Corporation		005050158	manufacture(79258-141) , label(79258-141) , analysis(79258-141) , pack(79258-141)