SUNTONE AFTER SUN BURN RELIEF GEL WITH LIDOCAINE (LIDOCAINE HYDROCHLORIDE) GEL [PRIME ENTERPRISES INC.]

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  • SUNTONE AFTER SUN BURN RELIEF GEL WITH LIDOCAINE (LIDOCAINE HYDROCHLORIDE) GEL [PRIME ENTERPRISES INC.]

SUNTONE AFTER SUN BURN RELIEF GEL WITH LIDOCAINE (LIDOCAINE HYDROCHLORIDE) GEL [PRIME ENTERPRISES INC.]
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NDC 58443-0125-6
Set ID 2bea8016-ad69-661d-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager Prime Enterprises Inc.
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART346
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  • Active Ingredients

    Lidocaine Hydrochloride (0.72%)

  • Purpose

    External Analgesic

  • Uses

    For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites or minor skin irritations.

  • WARNINGS

    For external use only.

    Avoid contact with the eyes.

    If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and contact a physician.

    Do not use in large quantities, particularly over raw surfaces or blistered areas.

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

  • Directions

    • Adults and children 2 years of age and older, apply to affected area not more than 3 to 4 times daily.
    • Children under 2 years of age: Ask a doctor
  • INACTIVE INGREDIENT

    Aloe Barbadensis Leaf Juice, Benzophenone-4, Blue 1, Carbomer, Diazolidinyl Urea, Disodium EDTA, DMDM Hydantoin, Fragrance, Menthol, Methylparaben, Polysorbate 20, Propylene Glycol, SD Alcohol 40-B, Triethanolamine, Water, Yellow 5

  • Questions or Comments?

    Biocycle Laboratories, Inc.

    16363 NW 49 Avenue, Miami, FL 33014

  • Suntone After Sun Burn Relief with Lidocaine

    Principal Display Image

  • INGREDIENTS AND APPEARANCE
    SUNTONE  AFTER SUN BURN RELIEF GEL WITH LIDOCAINE
    lidocaine hydrochloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0125
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS7.13 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SULISOBENZONE (UNII: 1W6L629B4K)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    MENTHOL (UNII: L7T10EIP3A)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0125-6470 mL in 1 BOTTLE; Type 0: Not a Combination Product11/07/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/07/2011
    Labeler - Prime Enterprises Inc. (101946028)
    Registrant - Prime Enterprises Inc. (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises Inc.101946028pack(58443-0125) , manufacture(58443-0125) , label(58443-0125)
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