Country: United States
Language: English
Source: NLM (National Library of Medicine)
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)
Scholls Wellness Company LLC
TOPICAL
OTC DRUG
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
OTC monograph final
SCHOLLS WELLNESS COMPANY LLC DURAGEL 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._ ---------- DURAGEL CALLUS REMOVER 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 (104ºF 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 SCHOLLS WELLNESS COMPANY LLC DURAGEL CALLUS REMOVER salicylic acid disc Scholls Wellness Company LLC PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:73469-0644 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 in 1 g Read the complete document