Label: ABREVA RAPID PAIN RELIEF- glycerin, lidocaine gel

  • NDC Code(s): 0135-0400-01
  • Packager: Haleon US Holdings LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 8, 2024

If you are a consumer or patient please visit this version.

  • Active ingredients

    Glycerin 20%

    Lidocaine HCl 4%

  • Purposes

    Lip Protectant

    External Analgesic

  • Uses

    for the temporary relief of pain and itching associated with cold sores and fever blisters
    Relieves dryness and softens cold sores and fever blisters
    Softens crust (scabs) associated with cold sores and fever blisters
  • Warnings

    For external use only

    Do not use

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

    When using this product

     
    do not get into eyes

    Stop use and ask a doctor if

    condition worsens
    symptoms last more than 7 days or clear up and occur 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

    push and turn cap to open, close tightly after use
    wash hands before and after applying
    adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
    children under 12 years: consult a doctor
  • Other information

    store at 20-25oC (68o-77oF)
  • Inactive ingredients

    edetate disodium, hydroxyethyl cellulose, menthol, methylparaben, polysorbate 80, propylene glycol,

    propylparaben, trisodium citrate dihydrate, water

  • Questions or comments?

    1-877-709-3539

  • Additional Information

    Retain outer carton for full product uses, directions and warnings.

    Do not use if carton is broken or damaged.

    CARTON Recycle

    Trademarks are owned by or licensed to the Haleon group of companies.

    Distributed by:

    Haleon

    Warren, NJ 07059

    Made in Canada

    ©2023 Haleon group of companies or its licensor.

  • Principal Display Panel

    abreva

    RAPID

    PAIN RELIEF

    Cold Sore

    MAX

    STRENGTH

    LIDOCAINE

    For rapid numbing effect

    Lidocaine HCl 4% / Glycerin 20%

    External Analgesic / Lip Protectant

    NET WT 3 g (0.10 oz)

    PA 202119 – Front Panel

    PA 202119 Abreva Rapid Pain Relief 3g
  • INGREDIENTS AND APPEARANCE
    ABREVA  RAPID PAIN RELIEF
    glycerin, lidocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0400
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN200 mg  in 1 g
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS40 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0400-011 in 1 PACKAGE06/01/2023
    13 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01706/01/2023
    Labeler - Haleon US Holdings LLC (079944263)