Label: KROGER ALOE VERA PAIN RELIEVING- lidocaine menthol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 November 29, 2012

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  • Active ingredients

    Lidocaine 0.7%
    Menthol  0.2%
  • Purpose

    External Analgesic
    External 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

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

    Keep out of the 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 area not more than 3 to 4 times daily
    • children under 2 years of age: do not use, ask a doctor.
  • Inactive ingredients

    Water, Alcohol Denat., Glycerin, Polysorbate 20, Carbomer, Aloe Barbadensis Leaf Juice, Benzophenone-4, Tocopherol, Imidazolidinyl Urea, Blue 1.
  • Principal Display Panel

    Kroger
    QUALITY GURANTEED
    Aloe Vera
    Pain
    Relieving
    Gel
    with
    Lidocaine
    and Menthol
    Sppthes
    Cools and
    Moisturizes

    NET WT 16 OZ (1 LB) 453 g
    ZKR016A0.jpg
  • INGREDIENTS AND APPEARANCE
    KROGER ALOE VERA  PAIN RELIEVING
    lidocaine menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-906
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE0.7 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SULISOBENZONE (UNII: 1W6L629B4K)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    IMIDUREA (UNII: M629807ATL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30142-906-19453 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/29/2012
    Labeler - THE KROGER CO (006999528)
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