Label: BLOSSOM PHARMACEUTICALS ANTIFUNGAL- antifungal cream

  • Category: HUMAN OTC DRUG LABEL

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.

Drug Label Information

Updated May 9, 2014

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  • Active Ingredient

    Active Ingredient                       Purpose

    Clotrimazole 1.0%                     Antifungal                          

  • Purpose


    • For treatment of most athlete's foot (tinea pedis), jock itch (tinea crusis), Ringworm (tinea corporis).
    • For the treatment of superficial skin infections caused by Yeast (Candida Albicans).
    • Relieves itching, scaling, cracking, burning, redness, soreness, irritation discomfort and chafing associated with jock itch.
  • Warnings

    Do not use:

    • Do not use on children under 2 years of age unless directed by a doctor.
    • Avoid contact with eyes.
    • For athletes foot and ringworm - if irritation occurs, or if there is no improvement within 4 weeks, discontinue use and consult a doctor.
    • For jock itch - if irritation occurs, or if there is no improvement within two weeks, discontinue use and consult a doctor.
    • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
  • Indications and Usage

    • Clean the affected area and dry thoroughly. Apply a layer of cream over affected area twice daily (morning and night) or as directed by a doctor.
    • Supervise children in the use of this product.
    • For athlete's foot, pay special attention to spaces between toes: wear well fitting, ventilated shoes, and change shoes and socks at least once daily.

  • Dosage and Administration

    • Foe athlete's foot and ringworm, use daily for 4 weeks.
    • For jock itch, use daily for 2 weeks.If conditions persist longer, consult a doctor.
    • This product is not effective on scalp or nails.
  • Keep Out Of Reach Of Children

    KEEP OUT Of REACH Of CHILDREN

  • INACTIVE INGREDIENTS

    Inactive Ingredients: Cetomicrogol 1000, Cetostearyl alcohol, Liquid paraffin, Methylparaben, Propylene glycol, Propylparaben, Purified water, White soft paraben

  • Principal Display Panel

    Blossom Antifungal Cream

    Blossom Antifungal.jpg

    Blossom Antifungal

  • INGREDIENTS AND APPEARANCE
    BLOSSOM PHARMACEUTICALS ANTIFUNGAL 
    antifungal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61767-231
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CETETH-20 (UNII: I835H2IHHX)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61767-231-0228.25 g in 1 TUBE
    2NDC:61767-231-01113 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C05/09/2014
    Labeler - Blossom Pharmaceticals (677381470)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blossom Pharmaceticals677381470manufacture(61767-231)