DailyMed - KLEENLINE ESSENTIALS ANTIBACTERIAL LOTIONSKIN CLEANSER- chloroxylenol liquid

NDC Code(s): 79258-841-04
Packager: Brady Industries

Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 16, 2024

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active ingredient
Chloroxylenol 0.4%

Chloroxylenol 0.4%
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KEEP OUT OF REACH OF CHILDREN
Keep out of reach of childtren. If swallowed, get medical help or contact poison control section right away

Keep out of reach of childtren. If swallowed, get medical help or contact poison control section right away
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PURPOSE
Antibacterial

Antibacterial
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INACTIVE INGREDIENT
Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Lauryl Sulfate, Ethylene Glycol Phenyl Ether, Cocamidopropyl Amine Oxide, Sodiun Chloride, Propylene Glycol, Sodium Benzoate, Glycol ...

Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Lauryl Sulfate, Ethylene Glycol Phenyl Ether, Cocamidopropyl Amine Oxide, Sodiun Chloride, Propylene Glycol, Sodium Benzoate, Glycol Distearate, Fragance, Lauramide MIPA, Sodium Hydroxide, Disodium Cocamido MIPA Sulfosuccinate, D&C Green 5, FD&C Yellow 5, Methylchlorosithiazolinone, Methylisothiazolinone
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INSTRUCTIONS FOR USE
Read entire label before using this product - Place enough product on your pam and scrub thoroughly over all surfaces of both hands. Risne with clean water.

Read entire label before using this product

Place enough product on your pam and scrub thoroughly over all surfaces of both hands. Risne with clean water.
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USER SAFETY WARNINGS
For external use only - when using this product avoid contact with eyes - If contact occurs rinse thoroughly wiht water - Stop use adn ask doctor if irriitation or rash occurs

For external use only

when using this product avoid contact with eyes

If contact occurs rinse thoroughly wiht water

Stop use adn ask doctor if irriitation or rash occurs

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INDICATIONS & USAGE
Anticacteial hand cleaner - use in daycare, hospitals, nursing homes, physicians offices, dental offices and clinics

Anticacteial hand cleaner

use in daycare, hospitals, nursing homes, physicians offices, dental offices and clinics

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DOSAGE & ADMINISTRATION
Place enough product on your palmand scrub thoroughly over all surfaces of both hands. Rinse with clean water

Place enough product on your palmand scrub thoroughly over all surfaces of both hands. Rinse with clean water
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warnings
For external use only - When using this product avoid contact with eyes - If contact occurs, rinse thoroughly with water - Stop use and ask doctor if irritation or rash occurs

For external use only

When using this product avoid contact with eyes

If contact occurs, rinse thoroughly with water

Stop use and ask doctor if irritation or rash occurs
Close
WARNINGS
For external use only - When using this product avoid contact with eyes - If contact occurs, rinse thoroughly with water - Stop use and ask doctor if irritation or rash occurs

For external use only

When using this product avoid contact with eyes

If contact occurs, rinse thoroughly with water

Stop use and ask doctor if irritation or rash occurs
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PRINCIPAL DISPLAY PANEL (What is this?)

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INGREDIENTS AND APPEARANCE

Product Information

KLEENLINE ESSENTIALS ANTIBACTERIAL LOTIONSKIN CLEANSER chloroxylenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:79258-841
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	4 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
2-ISOBUTYL-4-METHYLTETRAHYDROPYRAN-4-OL (UNII: VK5ZHH2T3F)
HEXYL SALICYLATE (UNII: 8F78EY72YL)
LINALOOL (UNII: D81QY6I88E)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)
WATER (UNII: 059QF0KO0R)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
VERDYL ACETATE (UNII: 5232EN3X2F)
2-TERT-BUTYLCYCLOHEXYL ACETATE (UNII: 364FV60913)
.GAMMA.-UNDECALACTONE (UNII: QB1T0AG2YL)
SODIUM CARBONATE (UNII: 45P3261C7T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM ALUMINIUM SILICATE (UNII: 058TS43PSM)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
HEXAHYDRO-4,7-METHANOINDEN-6-YL PROPIONATE (UNII: S3ASM14UAS)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
LAURIC ISOPROPANOLAMIDE (UNII: 82DUX3RRVU)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
ETHYLENE OXIDE (UNII: JJH7GNN18P)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
BENZYL ACETATE (UNII: 0ECG3V79ZJ)
2,6-DIMETHYL-5-HEPTENAL (UNII: Z331YX9EL9)
CALCIUM SILICATE (UNII: S4255P4G5M)
1-(2,3,8,8-TETRAMETHYL-1,2,3,4,5,6,7,8-OCTAHYDRONAPHTHALEN-2-YL)ETHANONE (UNII: 1GD7ODM28Y)
3-(3,4-METHYLENEDIOXYPHENYL)-2-METHYLPROPANAL (UNII: L65EG8H6PA)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)
.BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF)
4-ACETOXY-3-PENTYLTETRAHYDROPYRAN (UNII: 30E3255185)
DIHYDROMYRCENOL (UNII: 46L1B02ND9)
SODIUM BENZOATE (UNII: OJ245FE5EU)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:79258-841-04	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/16/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	505G(a)(3)	12/16/2024

Labeler - Brady Industries (034932657)

Registrant - Betco Corporation (005050158)

Name	Address	ID/FEI	Business Operations
Establishment
Betco Corporation		005050158	manufacture(79258-841) , label(79258-841)

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	RxCUI	RxNorm NAME	RxTTY
1	1150812	chloroxylenol 0.4 % Medicated Liquid Soap	PSN
2	1150812	chloroxylenol 4 MG/ML Medicated Liquid Soap	SCD
3	1150812	chloroxylenol 0.4 % Medicated Liquid Soap	SY

Label: KLEENLINE ESSENTIALS ANTIBACTERIAL LOTIONSKIN CLEANSER- chloroxylenol liquid

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Label: KLEENLINE ESSENTIALS ANTIBACTERIAL LOTIONSKIN CLEANSER- chloroxylenol liquid

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KLEENLINE ESSENTIALS ANTIBACTERIAL LOTIONSKIN CLEANSER- chloroxylenol liquid

Number of versions: 1

KLEENLINE ESSENTIALS ANTIBACTERIAL LOTIONSKIN CLEANSER- chloroxylenol liquid

KLEENLINE ESSENTIALS ANTIBACTERIAL LOTIONSKIN CLEANSER- chloroxylenol liquid

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KLEENLINE ESSENTIALS ANTIBACTERIAL LOTIONSKIN CLEANSER- chloroxylenol liquid

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