Drug Facts

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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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.

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 (SALICYLIC ACID)	SALICYLIC ACID	2.8 g in 140 g

Inactive Ingredients
Ingredient Name	Strength
.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

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:54427-001-01	1 JAR ( JAR) in 1 BOX	contains a JAR
1		140 g in 1 JAR	This package is contained within the BOX (54427-001-01)

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	Operations
PRZEDSIEBIORSTWO PRODUKCY JNO HANDLOWE ANTOM		366004067	manufacture

Revised: 12/2012 BIOARPIL USA, INC.