FDA.reportPublic FDA data

Biomax USA ANTIBACTERIAL HAND WASH

Manufacturer
Biomax Cosmetics
Effective date
2020-07-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:23:13

Label at a glance#

ProductBiomax USA ANTIBACTERIAL HAND WASH
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Indications and uses

• hand sanitizer to decrease bacteria on the skin • recommended for repeated use

Dosage and administration

Apply directly on hands, massage and rinse.

Label contents#

Full prescribing information#

Active ingredient:

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride..........0.13%

Purpose

OTC - PURPOSE SECTION

Antibacterial

Other ingredients:..............99.78%

INACTIVE INGREDIENT SECTION

Aqua/Water/Eau, Cocamidopropyl Betaine, PEG-150-distearate, Cocamide MEA, Alternifolia (Tea Tree Leaf Oil), Glycerin, Menthol, Menthyl Lactate, Parfum (Fragrance), Tetrasodium EDTA, Mica, Methylchloroisothiazolinone, Methylisothiazolinone, Magnesium chloride, Magnesium Nitrate, Citric Acid, CI 42090 (FD&C Blue 1).

Uses

INDICATIONS & USAGE SECTION

• hand sanitizer to decrease bacteria on the skin
• recommended for repeated use

Warnings

WARNINGS SECTION

FOR EXTERNAL USE ONLY. AVOID CONTACT WITH EYES. FOR USE WITH ADULT SUPERVISION. PRODUCT NOT TESTED ON ANIMALS.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply directly on hands, massage and rinse.

SPL UNCLASSIFIED SECTION

HEALTHCARE

Refreshing deep cleanser

NATURALLY CLEAN | SULFATE-FREE | PARABEN-FREE

Wash away dirt and grime with Tea Tree Hand Soap. This refreshing hand wash with tea tree oil deep cleans hands and invigorates the senses with the reviving scent of tea tree and peppermint. 

Fragrance: The reviving scent of tea tree provides an invigorating aromatherapy experience like no other.

Ingredient Spotlight: Contains the famous Tingle Complex-a blend of tea tree and peppermint that leaves a cooling, "tingling" sensation. Tea tree oil is a natural antiseptic and germicide with healing properties.

Manufactured by:

Biomax Cosmetics Inc.

Houston, TX

www.biomaxcosmetics.com

MADE IN USA

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN1
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD1
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY1
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77369-905-162022-01-28C16284748780-1d6a99b39-df7e-a426-e053-dadaa90af4c2Biomax ANTIBACTERIAL Tea Tree Mint HAND SOAP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77369-905-16Biomax USA ANTIBACTERIAL HAND WASH473 mL in 1 BOTTLESOAP4731

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77369-905BIOMAX USA ANTIBACTERIAL HAND WASH (BENZALKONIUM CHLORIDE) SOAP [BIOMAX COSMETICS]1Legacy NDC, 1 package rows20200731_3b603b21-d4fe-4e0e-bb8f-65bbf3e33dc9.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
77369-90577369-905-16

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
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
PEG-150 DISTEARATE6F36Q0I0ACIACT
COCO MONOETHANOLAMIDEC80684146DIACT
TEA LEAF OILVC855RRT77IACT
GLYCERINPDC6A3C0OXIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
MENTHYL LACTATE, (-)-2BF9E65L7IIACT
EDETATE SODIUMMP1J8420LUIACT
MICAV8A1AW0880IACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
MAGNESIUM CHLORIDE02F3473H9OIACT
MAGNESIUM NITRATE77CBG3UN78IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
FD&C BLUE NO. 1H3R47K3TBDIACT

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
1c62e9f1-43c2-4d01-b66f-d9c2ed7225e83b603b21-d4fe-4e0e-bb8f-65bbf3e33dc92020-07-28WarningsExact identifier
spl id: 1c62e9f1-43c2-4d01-b66f-d9c2ed7225e8
spl set id: 3b603b21-d4fe-4e0e-bb8f-65bbf3e33dc9

Reported adverse events (FAERS/openFDA)#

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