Label: REDICARE BURN GEL gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 October 9, 2019

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  • Active Ingredient

    Lidocaine HCl 2.0%

  • Purpose

    Topical pain relief

  • Uses

    Temporary pain relief for minor burns

  • Warnings

    For external use only

    Do not use

    • In large quantities, particularly over raw or blistered areas
    • near eyes, if this happens rinse thoroughly with water.

    Stop use and ask doctor

    if condition worsens or persists for more than 7 days or clears up and occurs 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

    • for adults and children 2 years and older: apply to affected area not more than 4 times daily
    • children under 2: do not use, consult a doctor
  • Inactive Ingredients

    • aloe vera
    • carbomer
    • germaben II
    • propylene glycol
    • purified water
    • menthol
    • triethanolamine
    • vitamin E acetate
  • PRINCIPAL DISPLAY PANEL

    REDICARE

    BURN GEL

    for minor burns, scalds & sunburn

    WITH ALOE VERA FOR BEST RELIEF

    3.5g / 1/8 oz.

    NDC 71105-500-01

    DRUG FACTS...

    Packet

  • INGREDIENTS AND APPEARANCE
    REDICARE BURN GEL 
    redicare burn gel gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71105-500
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    MENTHOL (UNII: L7T10EIP3A)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71105-500-0215 in 1 BOX10/09/2019
    1NDC:71105-500-013.3 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34610/09/2019
    Labeler - Redicare LLC (800149346)
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