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Hydrisalic

Dosage form: gel
Ingredients: SALICYLIC ACID 17mL in 100g
Labeler: Pedinol Pharmacal, Inc.
NDC Code: 0884-2211

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.

Hydrisalic®

Drug Facts

Active Ingredient

Salicylic Acid 17%

Purpose

Corn and Callus Remover

Uses
  • for the removal of corns and calluses
  • relieves pain by removing corns and calluses

Warnings
  • Avoid inhaling vapors
  • Extremely flammable
  • For external use only
  • Keep away from fire or flame
  • Cap tightly and store at room temperature, away from heat

Do not use if you

  • are diabetic
  • have poor blood circulation

When using this product
  • avoid contact with eyes
  • if product gets in the eye, flush with water for 15 minutes
  • do not use on irritated skin or on any area that is infected or reddened

KEEP OUT OF THE REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center immediately

Stop use and consult your doctor if discomfort persists

Directions
  • Wash affected area
  • may soak corn/callus in warm water for 5 minutes to assist in removal
  • dry thoroughly
  • apply small amount to sufficiently cover each corn/callus
  • let dry
  • repeat once or twice daily for up to 14 days until corn/callus is removed

Inactive ingredients

Caramel, flexible collodion, glycolic acid, hydroxypropyl cellulose, isopropyl alcohol (27%), red 40, water

Questions or comments?

Please call 1-800-PEDiNOL (733-4665) or visit us online at www.pedinol.com.

Manufactured for:
PEDiNOL Pharmacal Inc.
Farmingdale, NY 11735

PRINCIPAL DISPLAY PANEL - 14g Tube Carton

hydrisalic® gel

salicylic acid 17%

corn and callus remover

net wt. 0.5 fl. oz. (14g)

HYDRISALIC 
salicylic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0884-2211
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID17 mL  in 100 g
Inactive Ingredients
Ingredient NameStrength
CARAMEL 
PYROXYLIN 
GLYCOLIC ACID 
HYDROXYPROPYL CELLULOSE 
ISOPROPYL ALCOHOL 
FD&C RED NO. 40 
WATER 
Packaging
#Item CodePackage Description
1NDC:0884-2211-141 TUBE (TUBE) in 1 CARTON
114 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart358F01/06/2012
Labeler - Pedinol Pharmacal, Inc. (064737125)
Establishment
NameAddressID/FEIOperations
Hawkeye-Jensen Inc.006627228MANUFACTURE

Revised: 02/2012
 
Pedinol Pharmacal, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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