MedPath
FDA Approval

WISH RUBBING ALCOHOL 70%

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
LJ Pharma
DUNS: 914078633
Effective Date
June 18, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Isopropyl alcohol(70 mL in 100 mL)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

LJ Pharma

LJ Pharma

914078633

Products1

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

WISH RUBBING ALCOHOL 70%

Product Details

NDC Product Code
84809-001
Application Number
M003
Marketing Category
OTC Monograph Drug (C200263)
Route of Administration
TOPICAL
Effective Date
June 18, 2025
WATERInactive
Code: 059QF0KO0RClass: IACT
Code: ND2M416302Class: ACTIBQuantity: 70 mL in 100 mL

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Product label

image description


INDICATIONS & USAGE SECTION

Uses

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

DOSAGE & ADMINISTRATION SECTION

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.

WARNINGS SECTION

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 - ACTIVE INGREDIENT SECTION

Active Ingredient

Isopropyl Alcohol 70%

OTC - PURPOSE SECTION

Purpose

FIRST AID ANTISEPTIC

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


SPL UNCLASSIFIED SECTION

Other information

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

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Purified Water


© Copyright 2025. All Rights Reserved by MedPath