ISOPROPYL RUBBING ALCOHOL WINTERGREEN ORAZEN INC- isopropyl alcohol 70 % wintergreen liquid

Isopropyl Rubbing Alcohol Wintergreen by

Drug Labeling and Warnings

Isopropyl Rubbing Alcohol Wintergreen by is a Otc medication manufactured, distributed, or labeled by Orazen Inc, Onest Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (by volume)

Isopropyl alcohol (70% conc.)

Purpose

First aid antiseptic

Uses

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

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.

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

Other information

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

Inactive ingredient

purified water

Methyl Salicylate

FD&C Blue #1

FD&C Yellow # 5

Questions or comments?

Call toll-free 1-888-672-9360
(M-F 9AM-5:30PM EST)

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

QUALITY
GUARANTEED

Isopropyl Rubbing
Alcohol, 70%

Wintergreen

First Aid Antiseptic

For treatment of

• Minor Cuts
• Scrapes
• Burns

12 FL OZ
354 mL

Orazen Inc

Item # 02041

INGREDIENTS AND APPEARANCE

ISOPROPYL RUBBING ALCOHOL WINTERGREEN  ORAZEN INC
isopropyl alcohol 70 % wintergreen liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71927-028
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
METHYL SALICYLATE (UNII: LAV5U5022Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71927-028-01	354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/02/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	06/02/2025

Labeler - Orazen Inc (080916640)

Establishment
Name	Address	ID/FEI	Business Operations
Onest Ltd		767599018	manufacture(71927-028)