WESTERN FAMILY ALOE VERA MOISTURIZING (LIDOCAINE HYDROCHLORIDE) GEL [WESTERN FAMILY FOODS, INC.]

WESTERN FAMILY ALOE VERA MOISTURIZING (LIDOCAINE HYDROCHLORIDE) GEL [WESTERN FAMILY FOODS, INC.]
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NDC 55312-012-16
Set ID 6d3c13ae-23d3-4c30-b58e-3aece2125bd0
Category HUMAN OTC DRUG LABEL
Packager WESTERN FAMILY FOODS, INC.
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
  • Active ingredient

    Lidocaine HCl   0.5%


  • Purpose

    Topical Analgesic


  • Uses

    • temporary relief of pain and itching
    • helps relieve and soothes pain from sunburn, minor burns, cuts, scrapes, skin irritations and insect bites
  • Warnings

    For external use only

    Do not use

    in large quantities, particularly over raw surfaces or blistered areas.


    When using this product

    • avoid contact with eyes

    Stop use and ask a doctor if

    • condition worsens or if symptoms persist for more than 7 days.
    • symptoms clear up and occur again within a few days.

    Keep out of reach of children

    If 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 areas not more than 3 to 4 times daily
    • children under 2 years of age: do not use, ask a doctor
  • Inactive ingredients

    Water, Propylene Glycol, Glycerin, Isopropyl Alcohol, Triethanolamine, Polysorbate 80, Carbomer, Aloe Barbadensis Leaf Juice Powder, Menthol, Disodium EDTA, Diazolidinyl Urea, Yellow 5, Blue 1.


  • Principal Display Panel

    WESTERN FAMILY

    Aloe Vera

    MOISTURIZING GEL

    Sunburn Pain Relief

    with Lidocaine HCL

    clean, fresh fragrance soothes and moisturizes


    NET WT. 8 OZ. (226 g)

    Unghfrloed.jpg





  • INGREDIENTS AND APPEARANCE
    WESTERN FAMILY ALOE VERA MOISTURIZING 
    lidocaine hydrochloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55312-012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MENTHOL (UNII: L7T10EIP3A)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55312-012-16226 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/02/2014
    Labeler - WESTERN FAMILY FOODS, INC. (192166072)

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