Label: NAIL RENU ANTIFUNGAL- miconazole nitrate 2% cream

  • NDC Code(s): 76348-997-01, 76348-997-02
  • Packager: RENU LABORATORIES, INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 July 24, 2023

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  • ACTIVE INGREDIENT

    Miconazole Nitrate 2%

  • PURPOSE

    Antifungal

  • INDICATIONS & USAGE

    Uses

    • proven clinically to cure most:
    • athlete's foot (tinea pedis)
    • ringworm (tinea corporis)
    • Effectively soothes and relieves:
    • itching
    • burning
    • cracking
    • helps prevent most athlete's foot from coming back, with daily use
  • WARNINGS

    For external use only

  • WHEN USING

    When using this product, avoid contact with the eyes

  • STOP USE

    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.

  • INSTRUCTIONS FOR USE

    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
  • INACTIVE INGREDIENT

    Benxoic Acid, Ceramide-3, Ceteareth-20, Cetearyl Alcohol, Cinnamomum Zeylanicum (Cinnamon) Bark Oil, Dehydroacetic Acid, Deionized Water, Ethyl Macadamiate, Eucalyptol, Eugenia Caryophyllus (Clove) Bud Oil, Hippophae Rhamnoides (Sea Berry) Fruit and Seed Oils, Melaleuca Alternifolia (Tea Tree) Oil, Olea Europaea (Olive) Fruit Oil, Origanum vulgare (Oregano) Leaf Oil, Propylene Glycol, Thymol, Tocopherol, Triethanolamine, Trimethylpentanediol Adipic Acid Copolymer, Xanthan Gum

  • DO NOT USE

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

  • OTHER SAFETY INFORMATION

    Other Information

    Store at 68º - 77º (20 - 25 C)

  • STATEMENT OF IDENTITY

    NAIL RENU

    Miconazole Nitrate 2%

    Antifungal Cream

  • DOSAGE & ADMINISTRATION

    Directions

    • Clean the affected area and dry thoroughly
    • apply a thin coat over 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, change shoes and socks 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
  • PRINCIPAL DISPLAY PANEL

    NRFungal BOXproduct TUBETTUBE ARTWORK AND UNIT BOX ARTWORK FOR NAIL RENU

  • INGREDIENTS AND APPEARANCE
    NAIL RENU ANTIFUNGAL 
    miconazole nitrate 2% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76348-997
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE0.6 g  in 28 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    WATER (UNII: 059QF0KO0R)  
    EUCALYPTOL (UNII: RV6J6604TK)  
    CLOVE OIL (UNII: 578389D6D0)  
    HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741)  
    MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL (UNII: VIF565UC2G)  
    OREGANO LEAF OIL (UNII: 7D0CGR40U1)  
    HIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    THYMOL (UNII: 3J50XA376E)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CINNAMON BARK OIL (UNII: XE54U569EC)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    ETHYL MACADAMIATE (UNII: ANA2NCS6V1)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S) (UNII: 587WKM3S9Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76348-997-021 in 1 BOX07/24/2023
    1NDC:76348-997-0128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM00507/17/2023
    Labeler - RENU LABORATORIES, INC. (945739449)
    Establishment
    NameAddressID/FEIBusiness Operations
    Renu Laboratories, Inc.945739449manufacture(76348-997)
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