Label: LEADER AFTER SUN COOLING- lidocaine hydrochloride 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 4, 2022

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  • Active Ingredient

    Lidocaine hydrochloride 0.5%

  • Purpose

    External Analgesic

  • Uses

    temporarily relieves pain and itching due to:

    • minor skin irritations
    • sunburn
    • minor burns
    • scrapes
    • minor cuts
    • 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. If contact occurs, rinse with water to remove.
  • Stop use and ask a doctor if

    • condition gets worse
    • symptoms last more than 7 days
    • symptoms clear up and occur again in 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 area not more than 3 to 4 times daily.
    • children under 2 years of age: Ask a doctor
  • Other information

    may stain some fabrics

  • Inactive Ingredients

    aloe barbadensis leaf juice, water, isopropyl alcohol, propylene glycol, glycerin, triethanolamine, carbomer, polysorbate 80, diazolidinyl urea, menthol, disodium EDTA, yellow 5, blue 1

  • Label

    CL13898E-F

  • INGREDIENTS AND APPEARANCE
    LEADER   AFTER SUN COOLING
    lidocaine hydrochloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0534
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    WATER (UNII: 059QF0KO0R)  
    MENTHOL (UNII: L7T10EIP3A)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0534-1226 g in 1 BOTTLE; Type 0: Not a Combination Product11/04/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/04/2019
    Labeler - CARDINAL HEALTH, INC. (063997360)
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