Label: WALGREENS INSTANT TOOTHACHE AND GUM RELIEF TRIPLE MEDICATED- benzocaine, menthol, zinc chloride 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 January 11, 2023

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients

    Benzocaine 20%

    Menthol 0.5%

    Zinc Chloride 0.15%

  • PURPOSE

    Purpose

    Oral pain reliever

    Oral pain reliever

    Astringent

  • INDICATIONS & USAGE

    Use

    • for the temporary relief of oral pain due to minor irritation or injury of the mouth and gums
  • WARNINGS

    Warnings

    Methemoglobinemia warning: use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:

    • pale, gray, or blue colored skin (cyanosis)
    • headache
    • rapid heart rate
    • shortness of breath
    • dizziness or lightheadedness
    • fatigue or lack of energy

    Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics

    Do not use

    • more than directed
    • for more than 7 days unless directed by a dentist or doctor
    • for teething
    • in children under 2 years of age

    Stop use and ask a doctor if

    • swelling, reash or fever develops
    • irritation, pain or redness persists or worsens
    • symptoms do not improve in 7 days
    • allergic reaction occurs

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • cut open tip of tube on score mark
    • adults and children 2 years of age and older: apply a small amount of the product to the cavity and around the gum surrounding the teeth. Use up to 4 times daily or as directed by a dentist or doctor.
    • children between 2 and 12 years of age should be supervised in the use of this product
    • children under 2 years of age: do not use
  • OTHER SAFETY INFORMATION

    Other information

    • do not use if tip is cut prior to opening
    • this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted
    • do not use continuously
    • this formula will stay in place for extended duration of relief
    • avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying
  • INACTIVE INGREDIENT

    Inactive ingredientsblue 1, cellulose gum, gelatin, methyl salicylate, mineral oil, pectin, petrolatum, polyethylene glycol, sodium saccharin

  • SPL UNCLASSIFIED SECTION

    Questions or comments? 1-800-925-4733

    DISTRIBUTED BY: WALGREEN CO.

    200 WILMOT RD., DEERFIELD, IL 60015

    100% SATISFACTION GUARANTEED

    walgreens.com

  • PRINCIPAL DISPLAY PANEL

    Walgreens

    Instant Toothache & Gum Relief

    ORAL PAIN RELIEVER / ASTRINGENT

    SEVERE GEL TRIPLE MEDICATED

    • 20% maximum strength benzocaine for to relieve oral pain
    • Astringent to relieve gum irritation
    • Menthol to soothe

    NET WT 0.25 OZ (7.0 g)

    Walgreens Toothache Gum Relief Gel 2821380R1

  • INGREDIENTS AND APPEARANCE
    WALGREENS INSTANT TOOTHACHE AND GUM RELIEF   TRIPLE MEDICATED
    benzocaine, menthol, zinc chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-5351
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC CHLORIDE (UNII: 86Q357L16B) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.15 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.5 g  in 100 g
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE20 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PECTIN (UNII: 89NA02M4RX)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    GELATIN (UNII: 2G86QN327L)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-5351-091 in 1 CARTON03/06/2019
    17 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35603/06/2019
    Labeler - Walgreens (008965063)
    Registrant - Lornamead Inc. (080046418)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lornamead Inc.080046418manufacture(0363-5351)