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
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

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