SOLMATE BURN RELIEF GEL (LIDOCAINE HYDROCHLORIDE) GEL [PRIME ENTERPRISES, INC.]

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SOLMATE BURN RELIEF GEL (LIDOCAINE HYDROCHLORIDE) GEL [PRIME ENTERPRISES, INC.]
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NDC 58443-0263-7
Set ID 7d8f95ee-7cbc-9cc2-e053-2a91aa0a6210
Category HUMAN OTC DRUG LABEL
Packager Prime Enterprises, Inc.
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
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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, 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 

  • PRINCIPAL DISPLAY PANEL

    Principal Display Label

  • INGREDIENTS AND APPEARANCE
    SOLMATE  BURN RELIEF GEL
    lidocaine hydrochloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0263
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE7.1258 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:58443-0263-7591 mL in 1 BOTTLE; Type 0: Not a Combination Product12/21/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/21/2018
    Labeler - Prime Enterprises, Inc. (101946028)
    Registrant - Prime Enterprises, Inc. (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises, Inc.101946028label(58443-0263) , pack(58443-0263) , manufacture(58443-0263) , analysis(58443-0263)
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