MedPath

Isopropyl alcohol

Harris Teeter 810.003/810AA Isopropyl Alcohol 70%

Approved
Approval ID

b3fa1454-25cd-4801-bbec-5da43a70ec7f

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jul 30, 2025

Manufacturers
FDA

HARRIS TEETER

DUNS: 047279351

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 Code72036-810
Application NumberM003
Product Classification
M
Marketing Category
C200263
G
Generic Name
Isopropyl alcohol
Product Specifications
Route of AdministrationTOPICAL
Effective DateJuly 30, 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: 7/30/2025

Principal display panel

Harris Teeter™

70% Isopropyl Alcohol

First Aid Antiseptic

WARNING FLAMMABLE

  • Keep away from heat, spark, electrical, fire or flame
  • Do not use as fuel source

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

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

PROUDLY DISTRIBUTED BY:

HARRIS TEETER, LLC

MATTHEWS, NC 28105

yourplusguarantee.

1-800-432-6111 or harristeeter.com

16 FL OZ (1 PT) 473 mL

image descriptionimage description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 7/30/2025

Uses

First aid to help prevent the risk of infection in:

  • minor cuts
  • scrapes
  • burns

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 7/30/2025

Active ingredient

Isopropyl alcohol 70%

WARNINGS SECTION

LOINC: 34071-1Updated: 7/30/2025

Warnings

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

Flammable

  • keep away from fire or flame, heat, spark, electrical
  • do not use as a fuel source

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 7/30/2025

Stop use and ask a doctor if

condition persists or gets worse

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 7/30/2025

Purpose

First Aid Antiseptic

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 7/30/2025

Ask a Doctor before use

for deep or puncture wounds, animal bites or serious burns

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 7/30/2025

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

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 7/30/2025

Other information

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

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 7/30/2025

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
  • use only as directed

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 7/30/2025

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: 7/30/2025

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.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 7/30/2025

Inactive ingredient

water

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Isopropyl alcohol - FDA Drug Approval Details