FDA.reportPublic FDA data

Ethyl Rubbing Alcohol 70 Percent

Manufacturer
Humco Holding Group, Inc.
Effective date
2020-12-22
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:35:44

Label at a glance#

ProductEthyl Rubbing Alcohol 70 Percent
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

clean the affected area. apply a small amount of this product on the affected area 1 to 3 times daily. may be covered with sterile bandage. if bandaged, let it dry first.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% by volume

Purpose

OTC - PURPOSE SECTION

First aid antiseptic

Use

INDICATIONS & USAGE SECTION

First aid to help prevent the risk of infection in.

  • minor cuts
  • scrapes
  • burns

Warnings

WARNINGS SECTION

For external use only.

  • Flammable, keep way from spark, heat and flame.

Ask a doctor before use for

OTC - ASK DOCTOR SECTION

  • deep wounds
  • animal bites
  • serious burns

When using this product

OTC - WHEN USING SECTION

  • do not get into eyes
  • do not apply over large areas of the body
  • do not use longer than 1 week

Stop use and ask a doctor if

OTC - STOP USE SECTION

condition persists or gets worse

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • clean the affected area.
  • apply a small amount of this product on the affected area 1 to 3 times daily.
  • may be covered with sterile bandage.
  • if bandaged, let it dry first.

Other Information

OTHER SAFETY INFORMATION

  • store at room temperature
  • will produce serious gastric disturbances if taken internally.

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Acetone 5%

Methyl isobutyl ketone 1%

bitrex

purified water

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 46122-329-43
RUBBING ALCOHOL
ETHYL ALCOHOL 70%
USP
First Aid Antiseptic
16 fl oz (1 pt) 473 mL

Principal Display Panel NDC 46122-329-43 RUBBING ALCOHOL ETHYL ALCOHOL 70% USP First Aid Antiseptic 16 fl oz (1 pt) 473 mLPrincipal Display Panel NDC 46122-329-43 RUBBING ALCOHOL ETHYL ALCOHOL 70% USP First Aid Antiseptic 16 fl oz (1 pt) 473 mL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
582753ethanol 70 % Topical SolutionPSN3
582753ethanol 0.7 ML/ML Topical SolutionSCD3
582753ethanol 70 % Topical SolutionSY3
582753ethyl alcohol 70 % Topical SolutionSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0395-9100-162022-07-29C16284748780-1e4f33bdf-ab9f-d8a0-e053-dadaa90a6e4ePrivate Label Ethyl Rubbing Alcohol 70 Percent USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0395-9100-16Ethyl Rubbing Alcohol 70 Percent473 mL in 1 BOTTLELIQUID4733

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0395-9100ETHYL RUBBING ALCOHOL 70 PERCENT (ETHYL ALCOHOL) LIQUID [HUMCO HOLDING GROUP, INC.]3Legacy NDC, 1 package rows20201224_604007ca-e4ee-2b2c-e053-2a91aa0ac5c8.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0395-91000395-9100-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETONE1364PS73AFIACT
METHYL ISOBUTYL KETONEU5T7B88CNPIACT
DENATONIUM BENZOATE4YK5Z54AT2IACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

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
b71328b2-ab1e-1739-e053-2a95a90a5078604007ca-e4ee-2b2c-e053-2a91aa0ac5c82020-12-22WarningsExact identifier
spl id: b71328b2-ab1e-1739-e053-2a95a90a5078
spl set id: 604007ca-e4ee-2b2c-e053-2a91aa0ac5c8

Reported adverse events (FAERS/openFDA)#

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