TOTALLY FUN AFTER SUN (LIDOCAINE HCL) GEL [MJ PRODUCTS ASSOCIATION, LLC]

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TOTALLY FUN AFTER SUN (LIDOCAINE HCL) GEL [MJ PRODUCTS ASSOCIATION, LLC]
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NDC 72085-145-08
Set ID 965a2a29-914c-4ad0-b25f-5df3c30da393
Category HUMAN OTC DRUG LABEL
Packager MJ Products Association, LLC
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
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  • Drug Facts

  • Active Ingredients

    Lidocaine HCL 1.50%

    PURPOSE

    Topical Anesthetic

  • Indications

    For the Temporary relief of pain and itching due to sunburn, minor skin irritations, minor cuts, minor burns, scrapes and insect bites.

  • WARNINGS

    FOR EXTERNAL USE ONLY

    Do not use

    • in large quantites, particularly over raw or blistered areas.
    • Avoid contact with eyes.

    Stop use and ask a doctor

    • if condition gets worse, symptoms last for more than 7 days, or symptoms clear up and occur again with a few days.
    • If sumptoms persist for more than seven days, discontinue use and consult physician.

    Keep out of reach of children.

    If swallowed, consult physician.

  • Directions

    • Adults and children two-years of age or older: Apply to affected area not more than three to four times daily.
    • Children under two-years of age: consult a physician.
  • Additional information

    Store at room temperature.

  • Other Ingredients

    Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Carbomer, Ethylhexylglycerin, Glitter: Polyethylene Terephthalate, Polymethyl Methacrylate, Polyurethan-33, FD&C Yellow #5, D&C Red #7; Parfum (Orange Fragrance), Phenoxyethanol, Terephthalate, Triethanolamine.

  • Questions or comments?

    Contact us directly at 1-888-601-0441

    Distr. by/par: Sunshine & Glitter

    MJ Products Association LLC

    9750 NW 17th Street,  Miami, FL 33172

    www.sunshineglitter.com

    All Rights Reserved.

  • Package Labeling

    Totally Fun After Sun

  • INGREDIENTS AND APPEARANCE
    TOTALLY FUN AFTER SUN 
    lidocaine hcl gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72085-145
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS15 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72085-145-08236 mL in 1 BOTTLE; Type 0: Not a Combination Product03/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/01/2018
    Labeler - MJ Products Association, LLC (081022202)
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