Label: MAKESENSE JUNIOR 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

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

  • Active Ingredient

    Benzocaine 7.5%

  • Purpose

    Oral Pain Reliever

  • Uses

    for the temporary relief of sore gums due to teething in children 2 years of age and older. For use in children under the age of 2, consult a physician or healthcare provider.

  • Warnings

    Allergy alert: do not use this product if your baby 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 ask a dentist or 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

    ■ wash hands ■ cut open tip of tube on score mark ■ use your fingertip or cotton applicator to apply a small pea-size amount of MakeSense Junior Teething Gel and spread over gums ■ apply to affected area up to 4 times daily or as directed by a dentist or physician ■ 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  JUNIOR PAIN RELIEF
    benzocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69020-206
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE7.5 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:69020-206-1414 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)