Isopropyl Rubbing Alcohol Wintergreen
Isopropyl Rubbing Alcohol, 50% Wintergreen Orazen Inc. Our Brand
3716cdac-1770-5e53-e063-6294a90a7849
HUMAN OTC DRUG LABEL
Jun 8, 2025
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
Product Classification
Product Specifications
INGREDIENTS (5)
Drug Labeling Information
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

INDICATIONS & USAGE SECTION
Uses
- first aid to help prevent the risk of infection in minor cuts, scrapes and burns
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (by volume)
Isopropyl alcohol (50% conc.)
OTC - PURPOSE SECTION
Purpose
First aid antiseptic
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.
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
STORAGE AND HANDLING SECTION
Other information
- store at room temperature
- does not contain, nor is intended as a substitute for grain or ethyl alcohol
INACTIVE INGREDIENT SECTION
Inactive ingredient
purified water
Methyl Salicylate
FD&C Blue # 1
FD&C Yellow # 5
OTC - QUESTIONS SECTION
Questions or comments?
Call toll-free1-888-672-9360
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