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SANAFITIL (Tarmac Products, Inc)

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OINTMENT 1 TUBE in 1 CARTON (11096-190-01) > 28.35 g in 1 TUBE Label Information

Complete SANAFITIL Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • Active Ingredients

    Undecylenic Acid 10%


  • Purpose

    Antifungal


  • Uses

    • For the treatment of most athlete's foot, jock itch & ringworm
    • Relieves itching, burning, cracking, scaling and discomfort which accompany these conditions.

  • Warning

    • For external use only.

    • When using this product avoid contact with eyes and mucous membrane.

    • Do not use on children under 2 years of age except under the advice and supervision of a doctor.
    • Not for diaper rash

    Stop use and ask a doctor if
    • Irritation occurs
    • There is no improvement within 4 weeks of treatment for athlete's foot and ringworm and 2 weeks of treatment for jock itch discontinue use and consult a doctor.

    KEEP OUT OF REACH OF CHILDREN. In case of accidental ingestion seek professional assistance or contact a poison control center right away.


  • Directions

    • Clean affected area and dry thoroughly.
    • Apply a thin layer over affected area twice daily (morning and night) or as directed by a doctor.
    • For athlete's foot pay special attention to the space between the toes. Wear well fitting, ventilated shoes and change shoes & socks at least once a day.
    • For athlete's foot and ringworm, use daily for 4 weeks
    • For jock itch use daily for 2 weeks.
    • Supervise Children in use of this product.
    • Product not effective in the scalp or nails.

  • Other Information

    Store at 59° - 86° F (15°- 30°C)


  • Other ingredients

    petrolatum white, benzocaine, paraffin wax, salicylic acid, benzoic acid, boric acid, methyl salicylate, methyl paraben, propyl paraben, menthol crystals


  • PRINCIPAL DISPLAY PANEL - 28.35 g Tube Carton

    SANAFITIL®

    (Undecylenic Acid 10%)

    ANTIFUNGAL

    OINTMENT

    1 OZ. (28.35g)

    Principal Display Panel - 28.35 g Tube Carton

  • INGREDIENTS AND APPEARANCE
    SANAFITIL 
    undecylenic acid ointment
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:11096-190
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Undecylenic Acid (UNII: K3D86KJ24N) (Undecylenic Acid - UNII:K3D86KJ24N) Undecylenic Acid 100 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    PETROLATUM (UNII: 4T6H12BN9U)  
    BENZOCAINE (UNII: U3RSY48JW5)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    HEXYL SALICYLATE (UNII: 8F78EY72YL)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    BORIC ACID (UNII: R57ZHV85D4)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    MENTHOL (UNII: L7T10EIP3A)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11096-190-01 1 in 1 CARTON
    1 28.35 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333C 08/24/1966
    Labeler - Tarmac Products, Inc (059890491)
    Establishment
    Name Address ID/FEI Business Operations
    Tarmac Products, Inc 059890491 MANUFACTURE(11096-190)