UNICHEM

Manufacturer
Universal Chemical Products, Corp.
Effective date
2021-08-31
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:42:13

Label at a glance#

ProductUNICHEM
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

Clean affected area Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ehtyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

Helps prevent the risk of infection in minor cuts, scrapes and burns.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame

Do not use

OTC - DO NOT USE SECTION

  • in children less than 2 months of age
  • on open skin wounds

OTC - WHEN USING SECTION

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

  • Clean affected area
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Glutaraldehyde, purified water USP, Isopropyl Alcohol

Changes made to use the Hand Sanitizer template to register Regular Isopropyl Alcohol Products.

RECENT MAJOR CHANGES SECTION

Section 3: Use( Indications & Usage Section):

For cleaning minor cuts and preventing infections. It is not to subtitue when water or soap isn't readily available.

Date: june/2020

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

473 mL NDC: 82150-770-16

Ethyl Rubbing Alcohol 70% 16 ozEthyl Rubbing Alcohol 70% 16 oz

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82150-770-162023-01-30C16284748780-1f386c649-ecdb-0266-e053-dadaa90a7c1aEthyl Rubbing Alcohol 70%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82150-770-16UNICHEM473 mL in 1 BOTTLELIQUID4734

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82150-770UNICHEM (ETHYL RUBBING ALCOHOL 70%) LIQUID [UNIVERSAL CHEMICAL PRODUCTS, CORP.]4Legacy NDC, 1 package rows20210901_ca7ada6f-5b91-3d41-e053-2995a90a1170.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82150-77082150-770-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

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
cae0f182-c5da-bf6c-e053-2995a90a5e50ca7ada6f-5b91-3d41-e053-2995a90a11702021-08-31WarningsExact identifier
spl id: cae0f182-c5da-bf6c-e053-2995a90a5e50
spl set id: ca7ada6f-5b91-3d41-e053-2995a90a1170

Reported adverse events (FAERS/openFDA)#

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