FDA.reportPublic FDA data

Pearlescent

Manufacturer
Boelter Companies Inc. | Betco corporation, Ltd.
Effective date
2020-07-29
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:23:05

Label at a glance#

ProductPearlescent
Active ingredientCHLOROXYLENOL
Label structure8 sections

Label contents#

Full prescribing information#

Pearlescent

OTC - ACTIVE INGREDIENT SECTION

​Active Ingredient

Chloroxylenol 0.375%

Pearlescent

INDICATIONS & USAGE SECTION

Uses

  • ​​Antibacterial hand cleaner.
  • Use in daycare, hospitals, nursing homes, physicians offices, dental offices and clinics

Pearlescent

WARNINGS SECTION

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.

Pearlescent

DOSAGE & ADMINISTRATION SECTION

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

Pearlescent

INACTIVE INGREDIENT SECTION

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.

Pearlescent

OTC - PURPOSE SECTION

Purpose

Antibacterial

Pearlescent

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

Pearlescent

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Boelter - 141Boelter - 141

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57468-708-052025-01-30C16284748780-11030e365-3f62-111a-e063-dadaa90a10e2Pearlescent
57468-708-052024-10-01C16284748780-11030e365-3f62-111a-e063-dadaa90a10e2Pearlescent
57468-708-052024-07-30C16284748780-11030e365-3f62-111a-e063-dadaa90a10e2Pearlescent
57468-708-052024-01-30C16284748780-11030e365-3f62-111a-e063-dadaa90a10e2Pearlescent

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57468-708PEARLESCENT (CHLOROXYLENOL) SOAP [BOELTER COMPANIES INC.]4Legacy NDC20200730_861e1063-b9a8-2f09-e053-2991aa0abaf6.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 37 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57468-70857468-708-05

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 35 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
COCO DIETHANOLAMIDE92005F972DIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
MYRCENE3M39CZS25BIACT
LAURIC DIETHANOLAMIDEI29I2VHG38IACT
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28IACT
D&C GREEN NO. 58J6RDU8L9XIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
CHLOROXYLENOL0F32U78V2QACTIB
CALCIUM SILICATES4255P4G5MIACT
SODIUM LAURYL SULFATE368GB5141JIACT
DIMETHYL BENZYL CARBINYL BUTYRATE3Q0C60547RIACT
BENZYL BENZOATEN863NB338GIACT
DIOXANEJ8A3S10O7SIACT
SODIUM HYDROXIDE55X04QC32IIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
METHYL ALCOHOLY4S76JWI15IACT
.GAMMA.-DECALACTONE7HLS05KP9OIACT
MAGNESIUM NITRATE77CBG3UN78IACT
SODIUM ALUMINIUM SILICATE058TS43PSMIACT
SODIUM FERROCYANIDE5HT6X21AIDIACT
ETHYL ACETOACETATEIZP61H3TB1IACT
LAURIC ISOPROPANOLAMIDE82DUX3RRVUIACT
DIMETHYL BENZYL CARBINYL ACETATE6Y9488RL8HIACT
SODIUM CARBONATE45P3261C7TIACT
GLYCOL DISTEARATE13W7MDN21WIACT
METHYL ANTHRANILATE981I0C1E5WIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
ETHYL METHYLPHENYLGLYCIDATEUD51D5KR4AIACT
ETHYL BUTYRATEUFD2LZ005DIACT
ETHYLENE OXIDEJJH7GNN18PIACT
CHLOROACETIC ACID5GD84Y125GIACT
LINALOOL, (+/-)-D81QY6I88EIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
419afdbc-396c-23d5-e063-6294a90a7a0b861e1063-b9a8-2f09-e053-2991aa0abaf62025-10-20WarningsExact identifier
spl set id: 861e1063-b9a8-2f09-e053-2991aa0abaf6

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.