DailyMed - PEARLESCENT- chloroxylenol soap

NDC Code(s): 57468-141-05
Packager: Boelter Companies Inc.

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None

Drug Label Information

Updated December 26, 2024

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Pearlescent
Active Ingredient - Chloroxylenol 0.375%

Active Ingredient

Chloroxylenol 0.375%
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Pearlescent
Uses - Antibacterial hand cleaner. Use in daycare, hospitals, nursing homes, physicians offices, dental offices and clinics
Uses
- Antibacterial hand cleaner.
- Use in daycare, hospitals, nursing homes, physicians offices, dental offices and clinics
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Warnings - For external use only. Avoid contact with eyes. Children under the age of 6 should be supervised by an adult when using this product. Discontinue use is irritation or redness ...
Warnings
- For external use only.
- Avoid contact with eyes.
- Children under the age of 6 should be supervised by an adult when using this product.
- Discontinue use is irritation or redness develops.
- If irritation persists for more than 72 hours, consult a physician.
- KEEP OUT OF REACH OF CHILDREN.
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Pearlescent
Directions - Read the entire label before using this product. Dispense 1-2 pumps of product onto wet palm. Lather and rinse hands with clean water
Directions
- Read the entire label before using this product.
- Dispense 1-2 pumps of product onto wet palm.
- Lather and rinse hands with clean water
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Pearlescent
Inactive Ingredients - Water, Sodium Lauryl lSulfate, Cocamide DEA, Cocamidopropyl betadine, Phenoxyethanol, Sodium Laureth Sulfate, Propylene Glycol, Fragrance, DMDM Hydantoin, Glycol Stearate ...

Inactive Ingredients

Water, Sodium Lauryl lSulfate, Cocamide DEA, Cocamidopropyl betadine, Phenoxyethanol, Sodium Laureth Sulfate, Propylene Glycol, Fragrance, DMDM Hydantoin, Glycol Stearate, Laurimide DEA, Glycerine, Tocopheryl Acetate, D&C Green #5, FD&C Yellow #5.
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Pearlescent
Purpose - Antibacterial

Purpose

Antibacterial
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Pearlescent
KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN
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Pearlescent
...

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INGREDIENTS AND APPEARANCE

Product Information

PEARLESCENT chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:57468-141
Route of Administration	TOPICAL

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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:57468-141-05	3780 mL in 1 JUG; Type 0: Not a Combination Product	03/18/2013

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	505G(a)(3)	03/18/2013

Labeler - Boelter Companies Inc. (006436299)

Registrant - Betco corporation, Ltd. (024492831)

Name	Address	ID/FEI	Business Operations
Establishment
Betco Corporation, Ltd.		005050158	manufacture(57468-141) , pack(57468-141) , label(57468-141)

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Published Date (What is this?)	Version	Files
Dec 30, 2024	7 (current)	download
Dec 23, 2024	6	download
Jul 30, 2020	5	download
Apr 10, 2019	3	download
Apr 2, 2019	2	download

Published Date (What is this?)

Version

Files

Dec 30, 2024

7 (current)

download

Dec 23, 2024

download

Jul 30, 2020

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Apr 10, 2019

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Apr 2, 2019

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	RxCUI	RxNorm NAME	RxTTY
1	1362618	chloroxylenol 0.375 % Medicated Liquid Soap	PSN
2	1362618	chloroxylenol 3.75 MG/ML Medicated Liquid Soap	SCD
3	1362618	chloroxylenol 0.375 % Medicated Liquid Soap	SY

Label: PEARLESCENT- chloroxylenol soap

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Label: PEARLESCENT- chloroxylenol soap

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PEARLESCENT- chloroxylenol soap

Number of versions: 5

PEARLESCENT- chloroxylenol soap

PEARLESCENT- chloroxylenol soap

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PEARLESCENT- chloroxylenol soap

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.