BURN RELIEF (ALLANTOIN, LIDOCAINE, MENTHOL) CREAM [HUMN PHARMACEUTICALS INC]

BURN RELIEF (ALLANTOIN, LIDOCAINE, MENTHOL) CREAM [HUMN PHARMACEUTICALS INC]
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NDC 72042-003-03
Set ID 6c948545-cd5a-5371-e053-2a91aa0a7cc1
Category HUMAN OTC DRUG LABEL
Packager HUMN Pharmaceuticals Inc
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
  • ACTIVE INGREDIENT

    Active ingredients

    Allantoin 1.5% (w/w)

    Lidocaine Hydrochloride 4.0% (w/w)

    Menthol 1.0% (w/w)

  • PURPOSE

    Purpose

    Skin protectant

    Anesthetic

    Analgesic, anesthetic, and antipruritic

  • INDICATIONS & USAGE

    Uses

    Temporary relief of pain associated with:

    ▪ minor burns ▪ minor skin irritations

    Temporary protection of minor skin irritations

  • WARNINGS

    Warnings

    For external use only.

  • DO NOT USE

    Do not use

    in large quantities, particularly:

    • over raw surfaces • over blistered areas

  • ASK DOCTOR

    Ask a doctor before use

    if child is under 2 years of age, and use only as directed

  • WHEN USING

    When using this product

    • avoid contact with eyes; if this happens, rinse thoroughly with water

  • STOP USE

    Stop use and ask a doctor

    • condition worsens • if symptoms persist for more than 7 days

    • clear up and occur again within a few days • you experience: pain, swelling, or blistering

    • you experience: weakness, confusion, headache, difficulty breathing, or any unusual symptoms

    • you experience: pale, grey or blue-coloured skin, lips, or nail beds

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get

    medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.

  • INFORMATION FOR PATIENTS

    Other information

    • do not use if seal is broken

    • store at 60-85° F

  • INACTIVE INGREDIENT

    Inactive ingredients

    Acrylates/Acrylamide Copolymer, Alpha-Lipoic Acid, Beeswax, Butylene Glycol, C12-15 Alkyl Benzoate, C13-14 Isoparaffin, Caprylic/Capric Triglyceride, Caprylyl Glycol, Ceteraryl Alcohol, Ceteth-20, Ceteth-10 Phosphate, Denatured Alcohol, Dicetyl Phosphate, Dimethicone, Glycerin, Glyceryl Stearate, Iodopropynyl Butylcarbamate, Isopropyl Myristate, Laureth-7, Lecithin, Mineral Oil, PEG-6 Stearate, PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Polysorbate 85, Purified Water, Steareth-2, Steareth-20, Steareth-21.

  • QUESTIONS

    Questions?

    1-866-335-3596 Monday to Friday 8 am to 6 pm EST .

  • PRINCIPAL DISPLAY PANEL

    Burn Relief Label.jpg

    Burn Relief Label

  • INGREDIENTS AND APPEARANCE
    BURN RELIEF 
    allantoin, lidocaine, menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72042-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 mg  in 100 mg
    LIDOCAINE HYDROCHLORIDE ANHYDROUS (UNII: EC2CNF7XFP) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 mg  in 100 mg
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN1.5 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    CETETH-20 (UNII: I835H2IHHX)  
    ALCOHOL (UNII: 3K9958V90M)  
    ALUMINUM DICETYL PHOSPHATE (UNII: WMV3R5DS7O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PEG-6 STEARATE (UNII: 8LQC57C6B0)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    STEARETH-2 (UNII: V56DFE46J5)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)  
    PEG-120 GLYCERYL STEARATE (UNII: 6941286E4I)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    LAURETH-7 (UNII: Z95S6G8201)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DIMETHICONE 100 (UNII: RO266O364U)  
    POLYSORBATE 85 (UNII: A7F3N56197)  
    WATER (UNII: 059QF0KO0R)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    ACRYLAMIDE (UNII: 20R035KLCI)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    .ALPHA.-LIPOIC ACID (UNII: 73Y7P0K73Y)  
    STEARETH-21 (UNII: 53J3F32P58)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72042-003-031 in 1 CARTON05/19/2018
    128300 mg in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/16/2018
    Labeler - HUMN Pharmaceuticals Inc (245630272)
    Registrant - Delta Pharma Inc (200161730)
    Establishment
    NameAddressID/FEIBusiness Operations
    Delta Pharma Inc.200161730manufacture(72042-003)

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