País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)
Bayer HealthCare LLC.
SALICYLIC ACID
SALICYLIC ACID 0.4 g
OTC DRUG
OTC monograph final
DR. SCHOLLS ONE STEP CALLUS REMOVERS- SALICYLIC ACID DISC BAYER HEALTHCARE 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. SCHOLL'S ONE STEP CALLUS REMOVERS _DRUG FACTS_ ACTIVE INGREDIENT Salicylic acid 40% PURPOS E Callus remover US ES for 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 KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away. DIRECTIONS wash affected area and dry thoroughly apply medicated cushion after 48 hours , remove medicated cushion 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 ▪ 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 PRINCIPAL DISPLAY PANEL - 4 DISC CARTON DR. SCHOLLS ONE STEP CALLUS REMOVERS salicylic acid disc PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:11523-0 6 20 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 O IL (UNII: T5L8 T28 FGP) SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4) TALC (UNII: 7SEV7J4R1U) Bayer HealthCare LLC. PRODUCT CHARACTERISTICS COLOR bro wn (o paque so lid) S CORE S HAP E S IZ E FLAVOR IMPRINT CODE CONTAINS PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MA Leia o documento completo