Label: 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 May 1, 2010

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  • ACTIVE INGREDIENT

    Active Ingredient
    Benzocaine 7.5%
  • PURPOSE

    Purpose
    Anesthetic
  • INDICATIONS & USAGE

    Uses 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 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
    • 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 case of overdose or allergic reaction contact a Poison Control Center right away
  • DOSAGE & ADMINISTRATION

    Directions
    • wash your hands
    • use your fingertip or cotton applicator to apply a small pea-size amount of Budpack 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 to 25 C (59-77F)
       
  • INACTIVE INGREDIENT

    Inactive Ingredients Purified water, Glycerin, Propylene Glycol, Hydroxyethylcellulose, Carbomer, Sorbic Acid, Methylparaben, Propylparaben, FDC Yellow 5, FDC Red 40


  • PRINCIPAL DISPLAY PANEL

    Package Label
    image of package label

  • INGREDIENTS AND APPEARANCE
    BABY TEETHING ORAL PAIN RELIEVER 
    benzocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27293-013
    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
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBIC ACID (UNII: X045WJ989B)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:27293-013-011 in 1 BOX
    1NDC:27293-013-1414 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35605/01/2010
    Labeler - Budpak Inc. (183224849)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ausmetics Daily Chemicals (Guangzhou) Co. Ltd.529836561manufacture
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