MedPath

WISH RUBBING ALCOHOL 70%

Approved
Approval ID

edea3130-a766-4166-80b6-a93525f5a737

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jun 18, 2025

Manufacturers
FDA

LJ Pharma

DUNS: 914078633

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 Code84809-001
Application NumberM003
Product Classification
M
Marketing Category
C200263
G
Generic Name
Isopropyl Alcohol
Product Specifications
Route of AdministrationTOPICAL
Effective DateJune 18, 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: 6/16/2025

Product label

image description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 6/3/2025

Uses

First aid to help prevent the risk of infection in minor cuts, Scrapes & Burns.

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 6/3/2025

Other information

  • Store ate room temperature
  • Does not contain, nor is intended as a substitute for grain or ethyl alchol.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 6/3/2025

Inactive Ingredients

Purified Water

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 6/5/2025

Active Ingredient

Isopropyl Alcohol 70%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 6/3/2025

Purpose

FIRST AID ANTISEPTIC

WARNINGS SECTION

LOINC: 34071-1Updated: 6/3/2025

Warnings

*For external use only

  • IF taken internally, Serious gastric disturbances will result.Flammable , Keep away from fire or flame. *Use only in a well-ventilated area:Fumes may be toxic.

Ask a doctor before use if you have deepor puncture wounds, Animal bites or serious burns.

When using this product:

  • Do not get in eyes.
  • Do not Apply over large areas of the body.
  • Do not use longer than one week unless directed by doctor

Stop use and ask doctor ifconditions persist or get worse

Keep out of reach of children In case of ingestion , get medical help or contact a poison. control center right away.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 6/3/2025

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 6/3/2025

Directions

  • Clean the affected Area
  • Apply Small amount of this product on the area 1-3 times daily
  • Let the alcohol dry on skin before using bandages.
  • May be covered with a sterile bandag.

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WISH RUBBING ALCOHOL 70% - FDA Drug Approval Details