MedPath

Ethyl Rubbing Alcohol

Sunmark 876.002/876AL Ethyl Rubbing Alcohol

Approved
Approval ID

8356df29-8b56-4b4a-a773-4f3f0d486495

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 14, 2025

Manufacturers
FDA

STRATEGIC SOURCING SERVICES LLC

DUNS: 116956644

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Ethyl Alcohol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70677-0056
Application NumberM003
Product Classification
M
Marketing Category
C200263
G
Generic Name
Ethyl Alcohol
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 14, 2025
FDA Product Classification

INGREDIENTS (5)

ACETONEInactive
Code: 1364PS73AF
Classification: IACT
DENATONIUM BENZOATEInactive
Code: 4YK5Z54AT2
Classification: IACT
METHYL ISOBUTYL KETONEInactive
Code: U5T7B88CNP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALCOHOLActive
Quantity: 70 mL in 100 mL
Code: 3K9958V90M
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/14/2025

principal display panel

Sunmark ®

Ethyl rubbing alcohol 70% by volume

First Aid Antseptic

For rubbing and massaging

For treatment of minor cuts and scrapes

WARNING FLAMMABLE - Keep away from heat, spark, electrical, fire or flame

Use only in well-ventilated area; fumes can be harmful

CAUTION: Do not point at self or others; product will squirt when squeezed.

16 FL OZ (1 PT) 473 mL

image descriptionimage description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/14/2025

Use

first aid to help prevent the risk of infection in:

  • minor cuts
  • scrapes
  • burns

ADVERSE REACTIONS SECTION

LOINC: 34084-4Updated: 5/14/2025

ADVERSE REACTION

McKesson

Another Quality Product Distributed by McKesson

One Post Street, San Francisco, CA 94104

Money Back Guarantee

Please visit us at www.sunmarkbrand.com

DSP-TN-15000

DSP-MO-34

SDS-TN-15012

Pat. D675,101

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/14/2025

Purpose

First aid antiseptic

WARNINGS SECTION

LOINC: 34071-1Updated: 5/14/2025

Warnings

For external use only.

Flammable.

  • Keep away from fire or flame, heat, spark, electrical

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 5/14/2025

Ask a doctor before use

for deep or puncture wounds, animal bites or serious burns

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 5/14/2025

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

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 5/14/2025

Stop use and ask a doctor if

condition persists or gets worse

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 5/14/2025

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/14/2025

Active Ingredient

Ethyl alcohol 70%

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 5/14/2025

Other information

will produce serious gastric disturbances if taken internally

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/14/2025

Directions

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/14/2025

Inactive ingredient

acetone, denatonium benzoate, methyl isobutyl ketone, water

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Ethyl Rubbing Alcohol - FDA Drug Approval Details