Label: NAIL RENU- tolnaftate 1% solution

  • NDC Code(s): 76348-995-01, 76348-995-05
  • 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 March 22, 2023

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  • PURPOSE

    Purpose

    Antifungal

  • INDICATIONS & USAGE

    Uses

    • proven clinically to cure most Fungal nail and Skin infections including athlete's foot (tinea pedis) and ringworm (tinea corporis)
    • Effectively relieves itching, burning, cracking and scaling associated with the above conditions.
    • helps prevent most athlete's foot from coming back with daily use
  • WARNINGS

    Warnings

    • For external use only.
  • DO NOT USE

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

    • When using this product avoid contact with the eyes, nose, and mouth.
  • STOP USE

    Stop use and ask a doctor if

    • irritation occurs
    • there is no improvement within 4 weeks
    • if swallowed, get medical help or contact a Poison Control Center right away.
  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • PREGNANCY OR BREAST FEEDING

    If Pregnant or breastfeeding ask a health professional before use.

  • 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 intended for/or effective on the scalp.

  • OTHER SAFETY INFORMATION

    Other information

    • Store at 68º - 77º (20º - 25º C)
  • QUESTIONS

    Questions or Comments

    267-482-0866

    www.nailrenu.com

  • INACTIVE INGREDIENT

    Inactive Ingredients

    C12-15 Alkyl Benzoate, Camphor, Ceramide III, Cinnamonum Zeylanicum (Cinnamon) Bark Oil, Cymbopogon Nardus (Citronella) Oil, Ethoxydiglycol, Eugenia Caryophyllum (Clove) Bud Extract, Hippophae Rhamnoides (Sea Berry) Fruit and Seed Oils, Lavandula Angustifolia (Lavender) Oil, Limonene, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Mentha piperita (Peppermint) Leaf Oil, Olea Europaea (Olive Pomace) Oil, Oreganum Vulgare (Oregano) Leaf Oil, Pinene, Prunus Amygdallus Dulcis (Sweet Almond) Oil, Simmondsia Chinensis (Jojoba) Oil, Syzgium Aromatique (Clove) Bud Oil, Thymol, Tocopherol (Vitamin E), Trimethylpentanediol-Adipic Acid Copolymer

  • DOSAGE & ADMINISTRATION

    Directions

    • clean the affected area and dry thoroughly
      apply a thin layer over the affected area twice daily (morning and night)
  • ACTIVE INGREDIENT

    Tolnaftate

  • PRINCIPAL DISPLAY PANEL

    Nail RENU LABEL ART

    AND

    NAIL RENU

    BOX ART

    NRFungal Label 2

    NailRenu Box

  • INGREDIENTS AND APPEARANCE
    NAIL RENU 
    tolnaftate 1% solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76348-995
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CERAMIDE 3 (UNII: 4370DF050B)  
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    CLOVE OIL (UNII: 578389D6D0)  
    THYMOL (UNII: 3J50XA376E)  
    CITRONELLA OIL (UNII: QYO8Q067D0)  
    CLOVE (UNII: K48IKT5321)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    CINNAMON BARK OIL (UNII: XE54U569EC)  
    TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S) (UNII: 587WKM3S9Q)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741)  
    HIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J)  
    OREGANO LEAF OIL (UNII: 7D0CGR40U1)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    PINENE (UNII: 996299PUKB)  
    JOJOBA OIL (UNII: 724GKU717M)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76348-995-011 in 1 BOX03/22/2023
    1NDC:76348-995-0515 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM00503/22/2023
    Labeler - RENU LABORATORIES, INC. (945739449)
    Establishment
    NameAddressID/FEIBusiness Operations
    Renu Laboratories, Inc.945739449manufacture(76348-995)
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