SALACTIC FILM- salicylic acid liquid 
Pedinol Pharmacal, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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​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)

Pedinol salactic film - 0.5 fl. oz. (15 mL) bottle​

SALACTIC FILM 
salicylic acid liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0884-2592
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID170 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0884-2592-151 in 1 CARTON01/01/199105/03/2021
115 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358B01/01/199105/03/2021
Labeler - Pedinol Pharmacal, Inc. (064737125)
Establishment
NameAddressID/FEIBusiness Operations
Cospro Development Corp785638821MANUFACTURE(0884-2592)

Revised: 12/2018
Document Id: 39944386-3e70-4d1e-b2f1-734c9004c1a2
Set id: d370f7d5-5eca-412f-834f-1029001829ae
Version: 4
Effective Time: 20181204
 
Pedinol Pharmacal, Inc.