FREEZONE- salicylic acid liquid

Freezone by

Drug Labeling and Warnings

Freezone by is a Otc medication manufactured, distributed, or labeled by Medtech Products Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Salicylic acid 17.6% in a flexible collodion base

Purpose

Corn/Callus Remover

Use

For the removal of corns and calluses

Warnings

For external use only.

• Extremely flammable. Keep away from fire or flame.
• Cap bottle tightly and store at room temperature away from heat.

Do not use this product

• on irritated skin
• on any area that is infected or reddened
• if you are diabetic
• if you have poor blood circulation

Stop use and ask a doctor if

discomfort persists

When using this product

• avoid inhaling vapors
• avoid contact with eyes. If product gets into the eye, flush with water for 15 minutes.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

• Wash affected area.
• You may soak callus or corn in warm water for 5 minutes.
• Dry area thoroughly
• Apply one drop at a time to cover each corn or callus.
• Let dry.
• Repeat procedure once or twice daily as needed for up to 14 days (until corn or callus is removed).

Inactive Ingredients

alcohol 27%, ether 57%

Questions?

1-800-443-4908

Freezone® Liquid Corn & Callus Remover, 0.3 fl oz (9 mL)

INGREDIENTS AND APPEARANCE

FREEZONE 
salicylic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63029-104
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	158.4 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
ETHER (UNII: 0F5N573A2Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63029-104-03	1 in 1 BOX	10/01/1999
1		9 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358F	10/01/1999

Labeler - Medtech Products Inc. (122715688)