BIOARPIL- salicylic acid ointment

BIOARPIL by

Drug Labeling and Warnings

BIOARPIL by is a Otc medication manufactured, distributed, or labeled by BIOARPIL USA, INC., PRZEDSIEBIORSTWO PRODUKCY JNO HANDLOWE ANTOM. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Salicylic Acid 2%

PURPOSE

Purpose:

psoriasis and seborrheic dermatitis

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

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

WARNINGS

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

DOSAGE & ADMINISTRATION

Directions

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

INACTIVE INGREDIENT

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BIOARPIL 
salicylic acid ointment

Product 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)