Label: OLP BABY TEETHING- benzocaine gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 April 1, 2020

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  • Uses

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

    Warnings

    • Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as

    procaine, butacaine, benzocaine or other “caine” anesthetics

    • Do not use more than directed for more than 7 days unless told to do so by a dentist or doctor.
    • 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 dentist or doctor.
    • Stop use and ask a doctor if sore mouth symptoms do not get better in 7 days. swelling, rash or fever develops, irritation, pain or redness persists or worsens
    • Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
  • Purpose

    anaesthetic

  • Active Ingredient

    Benzocaine 7.5%

  • Other information

    store at 15 to 25 C(59-77F)

  • Directions

    • wash hands
    • cut open tip of tube on score mark
    • use your fingertip or cotton applicator to apply a small pea-size amount of baby teething gel
    • apply to affected area up to four times daily or as directed by a dentist or doctor

    for infants under 4 months of age, ask a dentist or doctor

  • Inactive ingredients

    FD&C yellow 5, FD&C Red 40, Flavor, Glycerin, Poropylene Glycols, Purified Water, Sorbic Acid, , carbomer, methyl paraben, propyl paraben

  • 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 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

    in case of overdose or allergic reaction contact a poison control center right away

  • questions

    www.ohiolabpharma.us

  • PRINCIPAL DISPLAY PANEL

    NET WEIGHT 0.33 oz (9.4g)

    NDC#70648-999-01

    olp baby teething gel

  • INGREDIENTS AND APPEARANCE
    OLP BABY TEETHING 
    benzocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70648-999
    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)  
    SORBIC ACID (UNII: X045WJ989B)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70648-999-011 in 1 CARTON12/06/2017
    19.4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B12/06/2017
    Labeler - Ohio Lab Pharma (080215854)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ohio Lab Pharma080215854manufacture(70648-999)
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