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FDA Approval

Isopropyl Rubbing Alcohol Wintergreen

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

FDA Approval Summary

Company
Orazen Inc
DUNS: 080916640
Effective Date
June 8, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Isopropyl alcohol(50 mL in 100 mL)

Manufacturing Establishments1

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

Onest Ltd

Orazen Inc

767599018

Products1

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

Isopropyl Rubbing Alcohol Wintergreen Orazen Inc

Product Details

NDC Product Code
71927-026
Application Number
505G(a)(3)
Marketing Category
OTC Monograph Drug (C200263)
Route of Administration
TOPICAL
Effective Date
June 8, 2025
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1MClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
Code: ND2M416302Class: ACTIBQuantity: 50 mL in 100 mL
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
METHYL SALICYLATEInactive
Code: LAV5U5022YClass: IACT

Drug Labeling Information

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

QUALITY
GUARANTEED

Isopropyl Rubbing
Alcohol, 50%

First Aid Antiseptic

For treatment of

  • Minor Cuts
  • Scrapes
  • Burns

12 FL OZ
354 mL

Orazen Inc

Item # 02039

![Our Brand Rubbing Alcohol 50 % Wintergreen](/dailymed/image.cfm?name=Our- brand-Rubbing-Alcohol-50+-+Winter-Green.jpg&id=880187)


INDICATIONS & USAGE SECTION

Uses

  • first aid to help prevent the risk of infection in minor cuts, scrapes and burns

DOSAGE & ADMINISTRATION SECTION

Directions

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

WARNINGS SECTION

Warnings

For external use only

Flammable, keep away from fire or flame.

*use only in a well-ventilated area; fumes may be toxic

  • if taken internally serious gastric disturbances will result

Ask a doctor before use if you have

  • deep or puncture wounds, animal bites or serious burns

When using this product

  • do not get into eyes
  • do not apply over large areas of the body
  • do not use longer than one week unless directed by a doctor

Stop use and ask a doctor if

  • condition persists or gets worse

**Keep out of reach of children.**In case of ingestion, get medical help or contact a Poison Control Center right away.


STORAGE AND HANDLING SECTION

Other information

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

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (by volume)

Isopropyl alcohol (50% conc.)

OTC - PURPOSE SECTION

Purpose

First aid antiseptic

OTC - QUESTIONS SECTION

Questions or comments?

Call toll-free1-888-672-9360
** (M-F 9AM-5:30PM EST)**


SPL UNCLASSIFIED SECTION

Drug Facts

INACTIVE INGREDIENT SECTION

Inactive ingredient

purified water

Methyl Salicylate

FD&C Blue # 1

FD&C Yellow # 5


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