BLOSSOM PHARMACEUTICALS ANTIFUNGAL (ANTIFUNGAL) CREAM [BLOSSOM PHARMACETICALS]

BLOSSOM PHARMACEUTICALS ANTIFUNGAL (ANTIFUNGAL) CREAM [BLOSSOM PHARMACETICALS]
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NDC 61767-231-01, 61767-231-02
Set ID 05403332-6978-4dba-8b94-9b9502eeb1c1
Category HUMAN OTC DRUG LABEL
Packager Blossom Pharmaceticals
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
  • 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)

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