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 Type HUMAN OTC DRUG Item Code (Source) NDC:54427-001
Route of Administration TOPICAL DEA Schedule     
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)

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.