Duragel Callus Remover (Scapa)

Scholls Wellness Company LLC by

Drug Labeling and Warnings

Scholls Wellness Company LLC by is a Otc medication manufactured, distributed, or labeled by Scapa Tapes North America LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SCHOLLS WELLNESS COMPANY LLC DURAGEL CALLUS REMOVER- salicylic acid disc 
Scapa Tapes North America LLC

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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Duragel Callus Remover (Scapa)

Drug Facts

Drug Facts

Active Ingredient

Active Ingredient Purpose

Salicylic Acid 40%........ Callus remover

Purpose

Callus remover

Uses

Uses

for the removal of calluses
relieves pain by removing calluses

Warnings

Warnings

For external use only

Do not use

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

Stop use and ask a doctor

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

Directions​

wash affected area and dry thoroughly

if necessary, cut medicated disc to fit callus

apply medicated disc with sticky side adhering to skin

cover medicated disc with enclosed cushion

after 48 hours, remove medicated disc

repeat procedure every 48 hours as needed for up to 14 days (until callus is removed)

may soak callus in warm water for 5 minutes to assist in removal

Other Information

Other information​

store between 20ºC to 25ºC (68º to 77ºF).

Protect from excessive heat (temperatures above 40ºC (104º​F

Inactive Ingredients

Inactive ingredients​ antioxidant
(CAS 991-84-4), iron oxides, mineral oil,

petroleum hydrocarbon resin, silicon dioxide,

synthetic polyisoprene rubber, talc

Questions

Questions? 1-866-360-3226

Duragel Callus Remover

SCHOLLS WELLNESS COMPANY LLC  DURAGEL CALLUS REMOVER
salicylic acid disc
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 66843-064
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.4 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
ANTIOXIDANT GS (UNII: 2BBL73FIEU)  
BROWN IRON OXIDE (UNII: 1N032N7MFO)  
MINERAL OIL (UNII: T5L8T28FGP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorbrownScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 66843-064-414 in 1 CARTON01/01/2021
11 g in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358F01/01/2021
Labeler - Scapa Tapes North America LLC (079995435)

Revised: 1/2022
Document Id: d6730d97-4a1d-ae16-e053-2a95a90a31f2
Set id: d6730d97-4a2b-ae16-e053-2a95a90a31f2
Version: 1
Effective Time: 20220125