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

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)

Available from:

Scholls Wellness Company LLC

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Callus remover Uses for the removal of calluses relieves pain by removing calluses 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

Authorization status:

OTC monograph final

Summary of Product characteristics

SCHOLLS WELLNESS COMPANY LLC DS EXTRA THICK CALLUS REMOVER-
SALICYLIC ACID DISC
SCHOLLS WELLNESS COMPANY 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._
----------
EXTRA THICK CALLUS REMOVERS
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. 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).
antioxidant (CAS 991-84-4), iron oxides, mineral oil, petroleum
hydrocarbon resin, silicon
dioxide, synthetic polyisoprene rubber, talc
Questions? 1-866-360-3226
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
Scholls Wellness Company LLC
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