Label: BIOARPIL- salicylic acid ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 54427-001-01 - Packager: BIOARPIL USA, INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated December 18, 2012
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- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BIOARPIL
salicylic acid ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54427-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 2.8 g in 140 g Inactive Ingredients Ingredient Name Strength .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) BIDENS TRIPARTITA FLOWERING TOP (UNII: 7378E9Z0AL) CALCIUM STEARATE (UNII: 776XM7047L) COD LIVER OIL (UNII: BBL281NWFG) EUCALYPTUS OIL (UNII: 2R04ONI662) HONEY (UNII: Y9H1V576FH) LAVENDER OIL (UNII: ZBP1YXW0H8) LYSOZYME HYDROCHLORIDE (UNII: 4YRW73H69V) MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) MINERAL OIL (UNII: T5L8T28FGP) PETROLATUM (UNII: 4T6H12BN9U) RETINOL (UNII: G2SH0XKK91) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54427-001-01 1 in 1 BOX 1 140 g in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 07/01/2012 Labeler - BIOARPIL USA, INC. (078675445) Establishment Name Address ID/FEI Business Operations PRZEDSIEBIORSTWO PRODUKCY JNO HANDLOWE ANTOM 366004067 manufacture(54427-001)