NAIL RENEW (TOLNAFTATE) LIQUID [NAILRENEW]

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NAIL RENEW (TOLNAFTATE) LIQUID [NAILRENEW]
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NDC 62858-101-11, 62858-101-51
Set ID a0df4ee5-1276-41b7-a1c4-8fcbfc7f97b5
Category HUMAN OTC DRUG LABEL
Packager NailRenew
Generic Name
Product Class
Product Number
Application Number PART333C
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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT

    TOLNAFTATE 1.0%

  • PURPOSE

    PURPOSE

    ANTIFUNGAL

  • INDICATIONS & USAGE

    USES

    • Helps cure most fungal nail and skin infections, including Tinea Corporis (Ringworm) and Tinea Pedis (Athlete's Foot).
    • Effectively relieves itching, burning, cracking and scaling accompanying the above conditions.
  • WARNINGS

    WARNINGS

    • For external use only.
    • In case of accidental ingestion contact a physician, emergency medical care facility or poison control center.
    • Stop use and ask a physician if rash or irritation occurs.
  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • DO NOT USE

    DO NOT USE

    • ON CHILDREN UNDER 2 UNLESS DIRECTED BY A DOCTOR.
    • NEAR OR IN EYES, EARS OR MOUTH.
  • QUESTIONS

    QUESTIONS? EMAIL: INFO@NAIL-RENEW.COM

  • DOSAGE & ADMINISTRATION

    DIRECTIONS

    • Clean affected area with soap and warm water and dry thoroughly.
    • Apply 2-3 drops twice daily (morning & evening) to affected areas; especially around free edges of nails (under tips) and cuticles and the space around the toes.
    • Allow solution to soak into nail or skin.
    • This product is not effective on scalp or hair.
    • Application to adjacent nails is recommended to prevent the spread of the infection. Keep affected areas clean and dry throughout the day.
  • INACTIVE INGREDIENT

    Water (Aqua), PEG-8, Glyceryl Stearate, Cetearyl Alcohol, Ceteth-20 Phosphate, Dicetyl Phosphate, Propylene Glycol, Aloe Barbadensis Leaf Juce, Coco-betaine, Octoxynol-9, Cetyl Alcohol, Stearyl Alcohol, Hydroxyethylcellulose, Imidazolidinyl Urea, Benzyl Alcohol, Propylparaben, Triethanolamine

  • PRINCIPAL DISPLAY PANEL

    NailRenew_BottleLabel_Front

    NailRenew_BottleLabel_Back-1

    NailRenew_BottleLabel_Back-2

  • INGREDIENTS AND APPEARANCE
    NAIL RENEW 
    tolnaftate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62858-101
    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
    WATER (UNII: 059QF0KO0R)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETETH-20 PHOSPHATE (UNII: 921FTA1500)  
    DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    COCO-BETAINE (UNII: 03DH2IZ3FY)  
    OCTOXYNOL-9 (UNII: 7JPC6Y25QS)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
    IMIDUREA (UNII: M629807ATL)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62858-101-511 in 1 BOX03/22/2014
    1NDC:62858-101-1130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C03/22/2014
    Labeler - NailRenew (960115710)
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