SALACTIC FILM- salicylic acid liquid

Salactic Film by

Drug Labeling and Warnings

Salactic Film by is a Otc medication manufactured, distributed, or labeled by Pedinol Pharmacal, Inc., Cospro Development Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

​Active ingredient

Salicylic acid 17%

Purpose

Wart remover

Use

• for the removal of common warts. The common wart is easily recognized by the rough “cauliflower-like” appearance of the surface.
• for the removal of plantar warts on the bottom of foot. The plantar wart is recognized by its location only on the bottom of the foot, its tenderness and the interruption of footprint pattern.

​Warnings

•   For external use only
•   Extremely Flammable
•   Keep away from fire or flame
•   Avoid inhaling vapors

Do not use

• if you are diabetic
• if you have poor blood circulation
• on irritated skin or any area that is infected or reddened
• on moles, birthmarks, warts with hair growing from them, genital warts, or warts on the face or mucous membranes

When using this product

• if product gets in eyes, flush with water for 15 minutes
• Cap bottle tightly when not in use and store at room temperature away from heat

Stop use and ask a doctor if

discomfort lasts

Keep out of reach of children.

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

​Directions

• wash affected area
• may soak wart in warm water for 5 minutes
• dry area thoroughly
• apply a small amount at a time with applicator to sufficiently cover each wart
• let dry
• repeat procedure once or twice daily as needed (until wart is removed) for up to 12 weeks

​Other information

• Store at controlled room temperature

Inactive ingredients

flexible collodian, glycolic acid, isopropyl alcohol, red 40, water, yellow 11

​Questions or comments?

1-800-321-4576 or visit us at www.pedinol.com

Principal Display Panel

NDC 0884-2592-15

PEDiNOL®
salactic film®

salicylic acid 17% USP

wart remover

0.5 fl. oz (15 mL)

​

INGREDIENTS AND APPEARANCE

SALACTIC FILM 
salicylic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0884-2592
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	170 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
PYROXYLIN (UNII: KYR8BR2X6O)
GLYCOLIC ACID (UNII: 0WT12SX38S)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
FD&C RED NO. 40 (UNII: WZB9127XOA)
WATER (UNII: 059QF0KO0R)
D&C YELLOW NO. 11 (UNII: 44F3HYL954)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0884-2592-15	1 in 1 CARTON	01/01/1991
1		15 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358B	01/01/1991

Labeler - Pedinol Pharmacal, Inc. (064737125)

Establishment
Name	Address	ID/FEI	Business Operations
Cospro Development Corp		785638821	MANUFACTURE(0884-2592)