BIOARPIL - salicylic acid ointment 
BIOARPIL USA, INC.

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.

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Drug Facts

Active Ingredient

Salicylic Acid 2%

Purpose:

psoriasis and seborrheic dermatitis

Keep out of reach of children. If swallowed, get immediate medical help or contact a Poison Control Center immediately.

Uses relieves and helps prevent recurrence of skin itching, irritation, redness, flaking, scaling due to psoriasis and seborrheic dermatitis

Warnings


Directions

Apply to affected area one to four times daily or as directed by a doctor

Inactive Ingredients

Alpha-Tocopherol Acetate, Bidens Tripartita Flower Top, Calcium Stearate, Cod Liver Oil, Eucalyptus Oil, Honey, Lavender Oil, Lysozyme Hydrochloride, Matricaria Recutita, Mineral Oil, Petrolatum, Retinol.


Product Label

BIOARPIL 
salicylic acid ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54427-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2.8 g  in 140 g
Inactive Ingredients
Ingredient NameStrength
.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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54427-001-011 in 1 BOX
1140 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H07/01/2012
Labeler - BIOARPIL USA, INC. (078675445)
Establishment
NameAddressID/FEIBusiness Operations
PRZEDSIEBIORSTWO PRODUKCY JNO HANDLOWE ANTOM366004067manufacture(54427-001)

Revised: 12/2012
Document Id: 5c12489e-f8df-4704-9d67-72b4277d1efe
Set id: e700b28f-268a-4384-a9bb-a83c42b41313
Version: 4
Effective Time: 20121218
 
BIOARPIL USA, INC.