Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)
Bayer Health Care LLC.
SALICYLIC ACID
SALICYLIC ACID 0.4 g
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
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 US ES _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 salicyclic acid disc PRODUCT INFORMATION Bayer Health Care LLC. PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:11523-0 6 44 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 0 .4 g INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH MINERAL Lesen Sie das vollständige Dokument