SCHOLLS WELLNESS COMPANY LLC DS EXTRA THICK CALLUS REMOVER- salicylic acid disc

Scholls Wellness Company LLC by

Drug Labeling and Warnings

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

Drug Details [pdf]

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

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

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 above 40º(104ºF).

INACTIVE INGREDIENT

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

QUESTIONS

Questions? 1-866-360-3226

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SCHOLLS WELLNESS COMPANY LLC  DS EXTRA THICK CALLUS REMOVER
salicylic acid disc

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73469-0463
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  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ANTIOXIDANT GS (UNII: 2BBL73FIEU)
MINERAL OIL (UNII: T5L8T28FGP)
TALC (UNII: 7SEV7J4R1U)
BROWN IRON OXIDE (UNII: 1N032N7MFO)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73469-0463-1	4 in 1 CARTON	01/01/2021
1		1 g in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M030	01/01/2021

Labeler - Scholls Wellness Company LLC (117174744)

Registrant - Scapa Tapes North America LLC (079995435)