Label: ORAJEL INSTANT PAIN RELIEF MAXIMUM STRENGTH- 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 March 20, 2012

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  • ACTIVE INGREDIENT

    Active Ingredients                  
    Benzalkonium chloride 0.02%           
    Benzocaine 20%                             
    Zinc chloride 0.1%                          
  • Purpose

    Purpose
    Oral antiseptic
    Oral pain reliever
    Pral astringent

  • INDICATIONS & USAGE

    Use    for the temporary relief of pain associated with canker sores, cold sores, fever blisters, minor irritation or injury of the mouth and gums. To help protect against infection in minor oral irritation.

  • Warnings

    Allergy Alert
    do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzcaine or other "caine" anesthetics

    Do not use
    more than is directed
    for more than 7 days unless directed by a dentist or doctor

    Stop use and ask a doctor if
    sore mouth symptoms do not improve in 7 days
    swelling, rash or fever develops
    irritation, pain or redness persists or worsens


  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.   In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions    cut open tip of tube on score mark,  do not use if tube tip is cut prior to opening

    Adults and children 2 years of age and over             Apply to affected are up to 4 times daily or as directed by dentist or doctor.

    Children under 12 years of age                                Should be supervised in the use of the product

    Children under 2 years of age                                  Ask a dentist or doctor

  • INACTIVE INGREDIENT

    Inactive ingredients allantoin, carbomer, edetate disodiu, mentha piperota (peppermint) oil, polyethylene glycol, polysorbate 60, propylene glycol, propyl gallate, purified water, pvp, sodium saccharin, sorbic acid, stearyl alcohol

    Questions or comments?  call us at 1-800-952-5080 M-F 9am-5pm or visit our website at www.orajel.com

  • Principal Display - carton

    TRIPLE MEDICATED for FAST
    EFFECTIVE RELIEF  
                   
    Orajel                  gel
    Instant Pain Relief
    For all Mouth Sores

    MAXIMUM STRENGTH

    SAFETY SEALED TUBE TIP
    NET WT 0.125 OZ (3.5g)            ORAL PAIN RELIEVER / ORAL ANTISEPTIC / ORAL ASTRINGENT

    carton imagecarton image

  • INGREDIENTS AND APPEARANCE
    ORAJEL INSTANT PAIN RELIEF  MAXIMUM STRENGTH
    benzocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-708
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.4 mg  in 1 g
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 g
    ZINC CHLORIDE (UNII: 86Q357L16B) (ZINC - UNII:J41CSQ7QDS) ZINC CHLORIDE1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z)  
    CARBOMER 934 (UNII: Z135WT9208)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    WATER (UNII: 059QF0KO0R)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBIC ACID (UNII: X045WJ989B)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10237-708-421 in 1 CARTON
    111.9 g in 1 TUBE
    2NDC:10237-708-181 in 1 CARTON
    25.1 g in 1 TUBE
    3NDC:10237-708-121 in 1 CARTON
    33.5 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35606/11/2010
    Labeler - Church & Dwight Co., Inc. (001211952)
    Establishment
    NameAddressID/FEIBusiness Operations
    Church & Dwight Co., Inc.043690812manufacture
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