MY FAIR BABY INSTANT PAIN RELIEF (BENZOCAINE) GEL [DELTA BRANDS INC]

MY FAIR BABY INSTANT PAIN RELIEF (BENZOCAINE) GEL [DELTA BRANDS INC]
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NDC 20276-560-01, 20276-560-14
Set ID 8b48d56c-7658-48ac-ab92-88d4c1fa14ec
Category HUMAN OTC DRUG LABEL
Packager Delta Brands Inc
Generic Name
Product Class
Product Number
Application Number PART356
  • 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)

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