Label: BUDPAK BABY TEETHING ORAL PAIN RELIEVER- 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 December 26, 2013

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  • ACTIVE INGREDIENT

    Active Ingredient

    Benzocaine 7.5%

  • PURPOSE

    Purpose

    Oral pain reliever

  • INDICATIONS & USAGE

    Use

    temporarily relieves sore gums due to teething in infants and children 4 months and older

  • WARNINGS

    Warnings

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

  • DO NOT USE

    Do not use

    • for more than 7 days unless told to do so by a physician
    • more than directed
  • WHEN USING

    When using this product

    • fever and nasal congestion are not symptoms of teething and may indicate the presence of infection. If these symptoms do not go away, advise your physician.
  • STOP USE

    Stop using and ask a dentist or 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

    Keep out of reach of children.

    In cases of overdose or allergic reaction, get medical help or contact a Poison Control Center right away

  • DOSAGE & ADMINISTRATION

    Directions

    • do not use if tube safety seal is broken
    • wash hands
    • break seal on tube
    • use your fingertip or cotton applicator to apply a small pea-size amount of Budpak Baby Teething Gel Medicine.
    • apply to affected area up to 4 times daily or as directed by a dentist or physician.
    • for infants under 4 months of age, ask a doctor
  • SPL UNCLASSIFIED SECTION

    Other information

    • Store at 15°C to 25 °C (59°F to 77°F)
    • Lot No. & Exp. Date: see crimp of tube
  • INACTIVE INGREDIENT

    Inactive Ingredients

    Glycyrrhizin Ammoniated, Glycerin, Polyethylene glycol, Purified water, Sodium saccharin, Sorbic acid, Sorbitol, Flavor, Red #40.

  • SPL UNCLASSIFIED SECTION

    PRINCIPAL DISPLAY PANEL

    BUDPAK BABY TEETHING PAIN RELIEVER GEL

    Benzocaine 7.5%

    NET WT 0.5 OZ. (14 g)

  • PRINCIPAL DISPLAY PANEL

    image of package label

  • INGREDIENTS AND APPEARANCE
    BUDPAK BABY TEETHING ORAL PAIN RELIEVER 
    benzocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27293-015
    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
    GLYCYRRHIZIN, AMMONIATED (UNII: 3VRD35U26C)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBIC ACID (UNII: X045WJ989B)  
    SORBITOL (UNII: 506T60A25R)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:27293-015-011 in 1 BOX
    1NDC:27293-015-1414 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35612/26/2013
    Labeler - Budpak Inc. (183224849)
    Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(27293-015)
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