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Isopropyl Rubbing Alcohol Wintergreen

Isopropyl Rubbing Alcohol, 50% Wintergreen Orazen Inc. Our Brand

Approved
Approval ID

3716cdac-1770-5e53-e063-6294a90a7849

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jun 8, 2025

Manufacturers
FDA

Orazen Inc

DUNS: 080916640

Products 1

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

Isopropyl alcohol 50 % Wintergreen

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code71927-026
Application Number505G(a)(3)
Product Classification
M
Marketing Category
C200263
G
Generic Name
Isopropyl alcohol 50 % Wintergreen
Product Specifications
Route of AdministrationTOPICAL
Effective DateJune 8, 2025
FDA Product Classification

INGREDIENTS (5)

FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ISOPROPYL ALCOHOLActive
Quantity: 50 mL in 100 mL
Code: ND2M416302
Classification: ACTIB
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
METHYL SALICYLATEInactive
Code: LAV5U5022Y
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 6/2/2025

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

LOINC: 34067-9Updated: 8/23/2019

Uses

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

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 6/2/2025

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 6/2/2025

Active ingredient (by volume)

Isopropyl alcohol (50% conc.)

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/23/2019

Purpose

First aid antiseptic

WARNINGS SECTION

LOINC: 34071-1Updated: 8/23/2019

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.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/23/2019

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

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 8/23/2019

Other information

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/23/2019

Inactive ingredient

purified water

Methyl Salicylate

FD&C Blue # 1

FD&C Yellow # 5

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 8/23/2019

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