MOLECULAR AF MOLECULAR CREAM CREAM [RENU LABORATORIES, INC.]

MOLECULAR AF MOLECULAR CREAM CREAM [RENU LABORATORIES, INC.]
PDF | XML

NDC 76348-402-01, 76348-402-02
Set ID 0fdc69e0-bb02-5de4-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Renu Laboratories, Inc.
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
  • Active Ingredient

    Miconazole Nitrate 2%

  • Purpose

    Antifungal

  • Warnings

    For external use only

    Do not use on children under 2 years of age unless directed by a doctor

    When using this product avoid contact with the eyes

    Stop use and ask a doctor if

    • irritation occurs
    • there is no improvement with 4 weeks

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

    Stop use and ask a doctor if

    • irritation occurs
    • there is no improvement within 4 weeks
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed,

    get medical help or contact a Poison Control

    Center right away

  • Directions

    Directions:

    • clean the affected area and dry thoroughly
    • apply a thin layer over the affected area twice daily (morning and night)
    • supervise children in the use of this product
    • for athlete's foot, pay special attention to the spaces between toes. Wear well-fitting, ventilated shoes, and
      change shoes and socks at least once daily.
    • use daily for 4 weeks. If condition lasts longer, ask a doctor
    • to prevent athlete's foot, apply to the feet once or twice daily
    • this product is not effective on the scalp or nails
  • Other Information

    • Store at 68° - 77º (20º - 25º C)
  • Inactive Ingredients

    Cetearyl Alcohol, Ceteareth-20, Cinnamonum Verum Oil, Citric Acid, Deionized Water, Emulsifying Wax NF, Ethyl Macadamiate,

    Glycerin (Veg.), Melaleuca Alternifolia Oil, Olea Europaea Oil, Origanum Vulgare Oil, Phenoxyethanol, Benzoic Acid,

    Dehydroacetic Acid, Propylene Glycol, Trimethylpentanediol / Adipic Acid Copolymer, Vitamin E Acetate, Xanthan Gum

  • DOSAGE & ADMINISTRATION

    Directions:

    • clean the affected area and dry thoroughly
    • apply a thin layer over the affected area twice daily (morning and night)
    • supervise children in the use of this product
    • for athlete's foot, pay special attention to the spaces between toes..
      Wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
    • use daily for 4 weeks. If condition lasts longer, as a doctor
    • to prevent athlete's foot, apply to the feet once or twice daily
    • this product is not effective on the scalp or nails
  • PRINCIPAL DISPLAY PANEL

    Molecular AF Tube art

  • BOX, Principal Display Panel

    Single Unit Box

  • INGREDIENTS AND APPEARANCE
    MOLECULAR AF MOLECULAR CREAM 
    molecular af molecular cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76348-402
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Miconazole Nitrate (UNII: VW4H1CYW1K) (Miconazole - UNII:7NNO0D7S5M) Miconazole Nitrate0.3 g  in 14 g
    Inactive Ingredients
    Ingredient NameStrength
    Benzoic Acid (UNII: 8SKN0B0MIM)  
    Water (UNII: 059QF0KO0R)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Glycerin (UNII: PDC6A3C0OX)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLAWAX POLYSORBATE (UNII: Q504PL8E0V)  
    TRIMETHYL-1,3-PENTANEDIOL (UNII: WT1X081P0L)  
    Tea Tree Oil (UNII: VIF565UC2G)  
    Cinnamon Oil (UNII: E5GY4I6YCZ)  
    Ethyl Macadamiate (UNII: ANA2NCS6V1)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Oregano Leaf Oil (UNII: 7D0CGR40U1)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Olive Oil (UNII: 6UYK2W1W1E)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Product Characteristics
    Colorwhite (Cream) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76348-402-021 in 1 BOX03/31/2015
    1NDC:76348-402-0114 g in 1 TUBE; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C03/31/2015
    Labeler - Renu Laboratories, Inc. (945739449)
    Establishment
    NameAddressID/FEIBusiness Operations
    Renu Laboratories, Inc.945739449manufacture(76348-402)

Related Drugs