Dr. Scholls Duragel Callus Removers

Dr. Scholls Duragel Callus Removers

Drug Labeling and Warnings

Drug Details

k">

DR. SCHOLLS DURAGEL CALLUS REMOVERS- salicyclic acid disc 
Bayer Health Care 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.

----------

Dr. Scholls Duragel Callus Removers

Drug Facts

Drug Facts

Active ingredient

Salicylic acid 40%

Callus remover

Uses

Uses

▪ for the removal of calluses

▪ relieves pain by removing calluses

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 if discomfort lasts

When using

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 20° to 25°C (68° to 77°F).

▪ Protect from excessive heat (temperatures above 40°C (104°F)).

Inactive ingredients

antioxidant (CAS 991-84-4), iron oxides, mineral oil, petroleum hydrocarbon resin, silicon dioxide, synthetic polyisoprene rubber, talc

Questions? 1- 866-360-3226

1 pack disc carton

Dr. Scholls Duragel Callus Removers

DR. SCHOLLS DURAGEL CALLUS REMOVERS 
salicyclic acid disc
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 11523-0644
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.4 g
Inactive Ingredients
Ingredient NameStrength
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: 11523-0644-11 in 1 CARTON02/01/2016
14 in 1 CELLO PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358F02/01/2016
Labeler - Bayer Health Care LLC. (112117283)

Revised: 11/2019
 
Bayer Health Care LLC.


© 2019 FDA.report
This site is not affiliated with or endorsed by the FDA.