Your browser does not support JavaScript! BIOARPIL (SALICYLIC ACID) OINTMENT [BIOARPIL USA, INC.]
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RxNorm Names

BIOARPIL (salicylic acid) ointment
[BIOARPIL USA, INC.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Sections

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

  • For external use only
  • Ask a doctor before use if condition covers a large part of the body
  • When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water
  • Stop use and ask a doctor if condition worsens or does not improve after regular use as directed


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 DRUG LABELItem Code (Source)NDC:54427-001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID2.8 g  in 140 g
Inactive Ingredients
Ingredient NameStrength
.ALPHA.-TOCOPHEROL ACETATE 
BIDENS TRIPARTITA FLOWERING TOP 
CALCIUM STEARATE 
COD LIVER OIL 
EUCALYPTUS OIL 
HONEY 
LAVENDER OIL 
LYSOZYME HYDROCHLORIDE 
MATRICARIA RECUTITA 
MINERAL OIL 
PETROLATUM 
RETINOL 
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
 
BIOARPIL USA, INC.

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