MedPath

70%

CVS 810.003/810AA 70% Isopropyl Alcohol

Approved
Approval ID

fbd9086c-39b2-449c-a06d-b85ec7d2dc72

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 28, 2025

Manufacturers
FDA

CVS Pharmacy, Inc

DUNS: 062312574

Products 1

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

Isopropyl alcohol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code59779-033
Application NumberM003
Product Classification
M
Marketing Category
C200263
G
Generic Name
Isopropyl alcohol
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 28, 2025
FDA Product Classification

INGREDIENTS (2)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
ISOPROPYL ALCOHOLActive
Quantity: 70 mL in 100 mL
Code: ND2M416302
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/28/2025

Principal display panel

CVS Health ®

Isopropyl Rubbing Alcohol

FIRST AID ANTISEPTIC

Rubbing & massaging

To decrease germs in minor cuts & scrapes

70%

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

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

Use only in a well-venutilated area; fumes may be harmful.

16 FL OZ (473 mL)

image descriptionimage description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/28/2025

Uses

helps prevent the risk of infection in:

  • minor cuts
  • scrapes
  • burns

ADVERSE REACTIONS SECTION

LOINC: 34084-4Updated: 5/28/2025

Advese reactions

Distributed by: CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

© 2024 CVS/pharmacy

CVS.com 1-800-SHOP CVS

CVS Quality

Money Back Guarantee

Pat. D675, 101

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 5/28/2025

Other information

  • does not contain, nor is intended as a substitute for grain or ethyl alcohol

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/28/2025

Inactive ingredient

water

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/28/2025

Active ingredient

Isopropyl alcohol 70%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/28/2025

Purpose

First Aid Antiseptic

WARNINGS SECTION

LOINC: 34071-1Updated: 5/28/2025

Warnings

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

**Flammable. Keep away from fire or flame, heat, spark, electrical**

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 5/28/2025

Ask a Doctor before use

if you have deep or puncture wounds, animal bites or serious burns

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 5/28/2025

When using this product

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

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 5/28/2025

Stop use and ask a doctor

if condition persists or gets worse

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 5/28/2025

Keep out of reach of children.

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

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 5/28/2025

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.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/28/2025

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

MedPath

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

© 2025 MedPath, Inc. All rights reserved.

70% - FDA Drug Approval Details