Label: BIOARPIL - salicylic acid ointment
- NDC Code(s): 54427-001-01
- Packager: BIOARPIL USA, INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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%Close
psoriasis and seborrheic dermatitisClose
- 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.Close
- INDICATIONS & USAGE
Uses relieves and helps prevent recurrence of skin itching, irritation, redness, flaking, scaling due to psoriasis and seborrheic dermatitisClose
- 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
Apply to affected area one to four times daily or as directed by a doctorClose
- INACTIVE INGREDIENT
Inactive IngredientsAlpha-Tocopherol Acetate, Bidens Tripartita Flower Top, Calcium Stearate, Cod Liver Oil, Eucalyptus Oil, Honey, Lavender Oil, Lysozyme Hydrochloride, Matricaria Recutita, Mineral Oil, Petrolatum, Retinol.
- INGREDIENTS AND APPEARANCE
salicylic acid ointment
Product Information Product Type HUMAN OTC DRUG LABEL 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 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)