Biomax USA

Manufacturer
Biomax Cosmetics
Effective date
2020-08-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:24:38

Label at a glance#

ProductBiomax USA
Active ingredientISOPROPYL ALCOHOL
Label structure8 sections

Indications and uses

• hand sanitizer to decrease bacteria on the skin • recommended for repeated use • for use when soap and water are not available

Dosage and administration

• supervise children under 6 years of age when using this product to avoid swallowing

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: 70% Isopropyl Alcohol

OTC - PURPOSE SECTION

Purpose: Antiseptic

USES

INDICATIONS & USAGE SECTION

• hand sanitizer to decrease bacteria on the skin

• recommended for repeated use

• for use when soap and water are not available

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Purified Water/aqua

WARNINGS

WARNINGS SECTION

For external use only. If taken internally serious gastric disturbances will result.

Flammable - keep away from heat, spark, electrical, fire or flame. Ask a doctor before use for deep or puncture wounds, animal bites or serious burns.

WHEN USING THIS PRODUCT:

• Do not get into eyes.

• Do not inhale.

• Do not apply over large areas of the body.

• Do not use longer than 1 week.

STOP USE AND ASK A DOCTOR IF CONDITION PERSISTS OR GETS WORSE.

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

• supervise children under 6 years of age when using this product to avoid swallowing

SPL UNCLASSIFIED SECTION

HEALTHCARE

ISOPROPYL RUBBING ALCOHOL 70%

WARNING: FLAMMABLE,

KEEP AWAY FROM FIRE OR FLAME

ANTISEPTIC

• Topical antiseptic and sanitizer

• Antibacterial Cleansing Agent

CAUTION: Fumes can be acutely irritating to skin, eyes and the respiratory system. Do not apply to irritated skin or if excessive irritation develops. Avoid getting into the eyes or on mucous membranes. Avoid inhaling this product.

Biomax Cosmetics Inc.

Houston, TX 77061

www.biomaxcosmetics.com

MADE IN USA

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
808520isopropyl alcohol 70 % Topical SolutionPSN1
808520isopropyl alcohol 0.7 ML/ML Topical SolutionSCD1
808520isopropyl alcohol 70 % Topical SolutionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77369-899-012022-01-28C16284748780-1d6a99b39-ae1a-a426-e053-dadaa90af4c2Bio max FIRST AID ANTISEPTIC
77369-899-162022-01-28C16284748780-1d6a99b39-ae1a-a426-e053-dadaa90af4c2Bio max FIRST AID ANTISEPTIC

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77369-899-01Biomax USA3785 mL in 1 BOTTLELIQUID37851
77369-899-16Biomax USA500 mL in 1 BOTTLELIQUID5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77369-899BIOMAX USA (ISOPROPYL ALCOHOL) LIQUID [BIOMAX COSMETICS]1Legacy NDC, 2 package rows20200814_5f40e4d1-eaff-4c2a-b9e2-bca9913712da.zip

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77369-89977369-899-16, 77369-899-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
ISOPROPYL ALCOHOLND2M416302ACTIB
WATER059QF0KO0RIACT

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
3ae6332a-9e21-460e-a344-6b30f00cd5a55f40e4d1-eaff-4c2a-b9e2-bca9913712da2020-08-10WarningsExact identifier
spl id: 3ae6332a-9e21-460e-a344-6b30f00cd5a5
spl set id: 5f40e4d1-eaff-4c2a-b9e2-bca9913712da

Reported adverse events (FAERS/openFDA)#

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