DR. SCHOLLS DURAGEL CALLUS REMOVERS- salicyclic acid disc

Dr. Scholls Duragel Callus Removers by

Drug Labeling and Warnings

Dr. Scholls Duragel Callus Removers by is a Otc medication manufactured, distributed, or labeled by Bayer Health Care LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Salicylic acid 40%

PURPOSE

Callus remover

Uses

Uses

▪ for the removal of calluses

▪ relieves pain by removing calluses

WARNINGS

Warnings

For external use only

DO NOT USE

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

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 INGREDIENT

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

1 pack disc carton

INGREDIENTS AND APPEARANCE

DR. SCHOLLS DURAGEL CALLUS REMOVERS 
salicyclic acid disc

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11523-0644
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.4 g

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11523-0644-1	1 in 1 CARTON	02/01/2016	06/30/2022
1		4 in 1 CELLO PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358F	02/01/2016	06/30/2022

Labeler - Bayer Health Care LLC. (112117283)