BABY TEETHING ORAL PAIN RELIEVER (BENZOCAINE) GEL [BUDPAK INC.]

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BABY TEETHING ORAL PAIN RELIEVER (BENZOCAINE) GEL [BUDPAK INC.]
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NDC 27293-013-01, 27293-013-14
Set ID bbf8ab75-9619-4a2a-86e0-6662c85198e1
Category HUMAN OTC DRUG LABEL
Packager Budpak Inc.
Generic Name
Product Class
Product Number
Application Number PART356
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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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