Label: CVS HEALTH AFTERSUN ALOE VERA COOLING- lidocaine gel

  • NDC Code(s): 69842-107-15, 69842-107-20
  • 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 November 9, 2022

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  • Active ingredients

    Lidocaine 0.5%

  • Purpose

    External Analgesic

  • Uses

    For the temporary relief of sunburn, minor burns, minor cuts, scrapes, insect bites, minor rashes, minor skin irritations and windburned skin.

  • Warnings

    • FOR EXTERNAL USE ONLY
  • Do not use

    in large quantities, particularly over raw surfaces or blistered areas.

  • When using this product

    • Keep out of eyes and eyelids. If contact with eyes occurs, rinse with water to remove.
  • Stop use and ask a doctor if

    • irritation or rash develops.
    • condition worsens, or if symptoms persist for more than 7 days or 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 3-4 times daily.
    • Children under 2 years of age: ask a doctor.
  • Inactive ingredients

    Aloe Vera Gel, Isoceteth-20, Triethanolamine, Carbomer 940, Tetrasodium EDTA, Methylchloroisothiazolinone (and) Methylisothiazolinone, Benzophenone-4, FD&C Blue #1.

  • Label

    CVS26649E1

    CVS34090E

  • INGREDIENTS AND APPEARANCE
    CVS HEALTH  AFTERSUN ALOE VERA COOLING
    lidocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-107
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SULISOBENZONE (UNII: 1W6L629B4K)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ISOCETETH-20 (UNII: O020065R7Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-107-15170 g in 1 BOTTLE; Type 0: Not a Combination Product10/23/2015
    2NDC:69842-107-20567 g in 1 BOTTLE; Type 0: Not a Combination Product10/23/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/23/2015
    Labeler - CVS Pharmacy (062312574)
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