Label: CVS HEALTH SUNBURN RELIEF COOLING LIDOCAINE 0.5 PAIN-RELIEVING- lidocaine hcl gel

  • NDC Code(s): 51316-022-15, 51316-022-20
  • Packager: CVS Pharmacy
  • 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 December 28, 2022

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  • Active ingredients

    Lidocaine 0.5% (as Lidocaine HCl)

  • Purpose

    External Analgesic

  • Uses

    For the temporary relief of pain and itching associated with sunburn, minor burns, minor cuts, scrapes, insect bites & minor skin irritations.

  • 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 worsens
    • symptoms persist for more than 7 days
    • symptomes clear up and occur again within a few days.
  • Keep out of reach of children.

    • If swallowed, seek medical help or contact a Poison Control Center immediately.
  • Directions

    • Adults and children 2 years 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, Benzophenone-4, Benzyl Alcohol, Blue 1, Carbomer, Isoceteth-20, Phenoxyethanol, Tetrasodium EDTA, Triethanolamine.

  • Label

    CVS38499A

  • INGREDIENTS AND APPEARANCE
    CVS HEALTH SUNBURN RELIEF COOLING LIDOCAINE 0.5 PAIN-RELIEVING 
    lidocaine hcl gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-022
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SULISOBENZONE (UNII: 1W6L629B4K)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ISOCETETH-20 (UNII: O020065R7Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-022-15170 g in 1 BOTTLE; Type 0: Not a Combination Product10/05/2018
    2NDC:51316-022-20567 g in 1 BOTTLE; Type 0: Not a Combination Product10/05/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/05/2018
    Labeler - CVS Pharmacy (062312574)
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