Label: MY FAIR BABY INSTANT 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 June 27, 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 physician 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 right away

  • Directions

    ■ wash your hands ■ use your fingertip or cotton applicator to apply a small pea-size amount of Oral Gel and spread over gums ■ apply to affected area up to 4 times daily or as directed by a physician or healthcare provider ■ for children under 2 years of age, consult a physician or health care provider

  • Other information

    do not use if tube seal under cap is broken, missing or if the tube tip is cut prior to opening

  • Inactive ingredients

    cellulose gum, flavor, gelatin, mineral oil, pectin, petrolatum, polyethylene glycol, red 40, sodium saccharin

  • Package Label

    image description

  • INGREDIENTS AND APPEARANCE
    MY FAIR BABY  INSTANT PAIN RELIEF
    benzocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20276-560
    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
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    GELATIN (UNII: 2G86QN327L)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PECTIN (UNII: 89NA02M4RX)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:20276-560-011 in 1 BOX
    1NDC:20276-560-1414 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35606/15/2014
    Labeler - Delta Brands Inc (102672008)