Label: MAKESENSE PAIN RELIEF- benzocaine 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 July 30, 2014

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  • Active Ingredient

    Benzocaine 20%

  • Purpose

    Oral Pain Reliever

  • Uses

    for the temporary relief of pain associated with:

    ■ toothache ■ canker sores ■ cold sores ■ fever blisters ■ minor dental procedures

  • Warnings

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

  • Do not use

    ■ more than directed ■ for more than 7 days unless directed by a physician or healthcare provider.

  • When using this product

    ■ fever and nasal congestion are not symptoms of teething and may indicate the presence of infection. If these symptoms persist, consult your physician

  • Stop use and aska doctor if

    ■ sore mouth symptoms do not get better in 7 days ■ irritation, pain or redness does not go away ■ swelling, rash or fever develops

  • Keep out of reach of children

    In case of overdose or allergic reaction get medical help or contact a Poison Control Center immediately.

  • Directions

    Adults and children 2 years of age and older:■ cut open tip of tube ■ apply to affected area up to 4 times daily or as directed by a dentist or physician ■ children under 12 years of age should be supervised using this product ■ for infants under 2 years of age, ask a doctor or health care provider

  • Other information

    ■ store at 59 to 77F (15-25C) ■ do not use if tube tip is cut prior to opening

  • Inactive ingredients

    Methylparaben, Mineral Oil, Ozocerite, Petrolatum, Propanediol, Propylparaben

  • Package Label

    image description

  • INGREDIENTS AND APPEARANCE
    MAKESENSE  PAIN RELIEF
    benzocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69020-207
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE20 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    CERESIN (UNII: Q1LS2UJO3A)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69020-207-1414 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35607/15/2014
    Labeler - Cherry Hill Sales Co (145959768)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ausmetics Daily Chemicals (Guangzhou) Co. Ltd.529836561manufacture(69020-207)
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