FDA.reportPublic FDA data

HOME FORMATION ANTIBACTERIAL SHEA BUTTER

Manufacturer
PATCOS COSMETICS (INDIA) PRIVATE LIMITED
Effective date
2021-02-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:37:59

Label at a glance#

ProductHOME FORMATION ANTIBACTERIAL SHEA BUTTER
Active ingredientBENZALKONIUM CHLORIDE
Label structure7 sections

Indications and uses

For hand washing to decrease bacteria on the skin.

Dosage and administration

• Pump into hands. • Lather vigorously for at least 15 seconds. • Rinse and dry thoroughly.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride (0.13%)

Purpose

OTC - PURPOSE SECTION

Antibacterial

Warnings

WARNINGS SECTION

For external use only.
When using this product avoid contact with eyes . In case of eyes contact, flush with water.

Stop use and ask a doctor if irritation and redness develops.

Keep out of reach of children if swallowed, get medical help or contact a Poison control center right away.

Uses

INDICATIONS & USAGE SECTION

For hand washing to decrease bacteria on the skin.

Directions

DOSAGE & ADMINISTRATION SECTION

• Pump into hands.
• Lather vigorously for at least 15 seconds.
• Rinse and dry thoroughly.

Inactive ingredient

INACTIVE INGREDIENT SECTION

Water, Sodium Laureth Sulphate,Sodium Laureth sulfate & Glycol Distearate & Cocamide MEA & Laureth - 10, Cocamido Propyl Betaine,
Cocomonoethanolamide, Sodium Chloride, Glycerine,Perfume, PEG 150 Distearate, Bronopol, Disodium EDTA,Phenoxyethanol, Benzophenone 3, Citric Acid, CI. No. 17200,  FD and C Yellow 5,CI. No. 19140 , D and C Red 33.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN2
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD2
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY2
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68121-005-012024-01-30C16284748780-11030e365-2e4d-111a-e063-dadaa90a10e26bfef619-5dff-488e-b3c8-1c982fdced39

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68121-005-01HOME FORMATION ANTIBACTERIAL SHEA BUTTER333 mL in 1 BOTTLELIQUID3332

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68121-005HOME FORMATION ANTIBACTERIAL SHEA BUTTER (BENZALKONIUM CHLORIDE) LIQUID [PATCOS COSMETICS (INDIA) PRIVATE LIMITED]2Legacy NDC, 1 package rows20210211_6bfef619-5dff-488e-b3c8-1c982fdced39.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68121-00568121-005-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM CHLORIDE451W47IQ8XIACT
GLYCERINPDC6A3C0OXIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
COCO MONOETHANOLAMIDEC80684146DIACT
PEG-150 DISTEARATE6F36Q0I0ACIACT
BRONOPOL6PU1E16C9WIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
PHENOXYETHANOLHIE492ZZ3TIACT
BENZOPHENONE701M4TTV9OIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
WATER059QF0KO0RIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
D&C RED NO. 339DBA0SBB0LIACT
LAURETH-10BD7AST04GAIACT
GLYCOL DISTEARATE13W7MDN21WIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

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
bafd9bbb-06ef-c450-e053-2a95a90a972e6bfef619-5dff-488e-b3c8-1c982fdced392021-02-10WarningsExact identifier
spl id: bafd9bbb-06ef-c450-e053-2a95a90a972e
spl set id: 6bfef619-5dff-488e-b3c8-1c982fdced39

Reported adverse events (FAERS/openFDA)#

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