Label: MAXIMUM STRENGTH BURN RELIEF ALOE GEL SCHERER LABS- lidocaine hydrochloride 4.00% 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 May 29, 2018

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  • ACTIVE INGREDIENT

    Active ingredients                            Purpose

    Lidocaine Hydrochloride - 4.00%      Topical analgesic

  • PURPOSE

  • INDICATIONS & USAGE

    Uses

    For the temporary relief of pain and itching
    due to • sunburn • minor burns • insect bites
    • minor cuts • scrapes • minor skin irritation

  • WARNINGS

    Warnings
    For external use only.
    When using this product • avoid contact with
    eyes. Rinse with water if contact occurs.
    Stop use and ask doctor if • if symptoms persist
    for more than 7 days.
    Do not use in large quantities, particularly over raw
    surfaces or blistered areas.

  • Keep out of the reach of children

  • DOSAGE & ADMINISTRATION

    Directions

    • Adults and children 2 years and
    older: apply to affected area not more than 3-4 times
    a day. • Children under 2 years
    of age: consult a physician.

  • INACTIVE INGREDIENT

    Inactive ingredients

    Aloe Barbadensis Leaf Extract, Avena
    Sativa (Oat) Kernel Extract, Blue
    1, Caprylyl Glycol, Chlorphenesin,
    Dimethyl Isosorbide, Glycerin,
    Hydroxyethylcellulose, Isopropyl
    Alcohol, Phenoxyethanol,
    Polysorbate 20, Propanediol,
    Tocopheryl Acetate, Water.

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    MAXIMUM STRENGTH BURN RELIEF ALOE GEL  SCHERER LABS
    lidocaine hydrochloride 4.00% gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64048-5002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Lidocaine Hydrochloride (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    OAT (UNII: Z6J799EAJK)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Chlorphenesin (UNII: I670DAL4SZ)  
    Dimethyl Isosorbide (UNII: SA6A6V432S)  
    Glycerin (UNII: PDC6A3C0OX)  
    Isopropyl Alcohol (UNII: ND2M416302)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Polysorbate 20 (UNII: 7T1F30V5YH)  
    Propanediol (UNII: 5965N8W85T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64048-5002-4118 mL in 1 BOTTLE; Type 0: Not a Combination Product04/08/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/08/2016
    Labeler - Product Quest Mfg. (927768135)
    Registrant - Product Quest Mfg. (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg.927768135manufacture(64048-5002) , label(64048-5002)
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