Label: SOLMATE BURN RELIEF GEL- lidocaine hydrochloride gel

  • Category: HUMAN OTC DRUG LABEL

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 January 29, 2015

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  • PRINCIPAL DISPLAY PANEL - 591 mL  Bottle Label

    PRINCIPAL DISPLAY PANEL - 591 mL Bottle Label

    SOL

    MATE

    LOVE THE SUN

    BURN RELIEF GEL

    External Analgesic

    with Lidocaine

    Contains

    Skin Moisturizing

    Aloe Vera

    20 FL OZ (591 mL)

  • 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, discountinue use of this product and consult 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 afftected area not more than 3 to 4 times daily.
    • Children under 2 years of age: ask a doctor.
  • Inactive ingredients

    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 

  • INGREDIENTS AND APPEARANCE
    SOLMATE  BURN RELIEF GEL
    lidocaine hydrochloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0145
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE0.057 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BENZOPHENONE (UNII: 701M4TTV9O)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    MENTHOL (UNII: L7T10EIP3A)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALCOHOL (UNII: 3K9958V90M)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0145-7591 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/01/2015
    Labeler - Prime Enterprises, Inc. (101946028)
    Registrant - Prime Enterprises, Inc. (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises, Inc.101946028label(58443-0145) , pack(58443-0145) , manufacture(58443-0145) , analysis(58443-0145)
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