50 WINTERGREEN ALCOHOL- alcohol liquid

50 Wintergreen Alcohol by

Drug Labeling and Warnings

50 Wintergreen Alcohol by is a Otc medication manufactured, distributed, or labeled by Iron Lab SA de CV. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

Thoroughly cover your hands with product and allow to dry without wiping. Children under 6 years of age should be supervised when using this product. Not recommended for infants.

INDICATIONS & USAGE

Thoroughly cover your hands with product and allow to dry without wiping. Children under 6 years of age should be supervised when using this product. Not recommended for infants.

INACTIVE INGREDIENT

purified water, methyl salicylate, FD&C Blue #1, FD&C Yelloww #5

OTHER SAFETY INFORMATION

Store below 105°F. May discolor some fabrics. Harmful to wood finishes and plastic

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center right away

ASK DOCTOR

Irritation or redness develops. Condition persist for more than 72 hours.

WARNINGS

For external use only: hands. Flammable, Keep away from fire of flame.

ACTIVE INGREDIENT

50% Ethyl Alcohol

PURPOSE

Antiseptic Alcohol

DO NOT USE

Keep out of eyes. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest.

PRINCIPAL DISPLAY PANEL

WinterGreen 50

INGREDIENTS AND APPEARANCE

50 WINTERGREEN ALCOHOL 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74375-040
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	50 mL  in 100 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74375-040-01	355 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/07/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	04/07/2025

Labeler - Iron Lab SA de CV (951575800)

Registrant - Iron Lab SA de CV (951575800)

Establishment
Name	Address	ID/FEI	Business Operations
Iron Lab SA de CV		951575800	manufacture(74375-040)