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Orajel for Codl Sores Relief and Concealer (Church & Dwight Co., Inc.)

Available Formats

Dosage Form Package Information Links
CREAM 1 TUBE, WITH APPLICATOR in 1 BLISTER PACK (10237-726-05) > 1.4 g in 1 TUBE, WITH APPLICATOR Label Information

Complete Orajel for Codl Sores Relief and Concealer Information

  • ACTIVE INGREDIENT

    Active Ingredients         Purpose

    Allantoin 0.5%               Skin protectant

    Benzocaine 20%           Topical analgesic

    Camphor 3%                 Topical analgesic

    Dimethicone 2%            Skin protectant

    Menthol 1%                   Topical analgesic

    White petrolatum 64%   Skin protectant


  • PURPOSE

    Uses   temporarily relieves pain and dryness; softens crust (scabs) associated with cold sore, fever blisters


  • DO NOT USE

    Warnings

     For external use only

    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 for more than 7 days unless told to do so by a dentist or doctor

    When using this product do not get into eyes

    Stop use and ask a doctor if conditions worsens; symptoms do not improve in 7 days; symptoms clear up and occur again within a few days

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



  • ASK DOCTOR

    Directions

    twist base clockwise ot dispense.  On first usage, it may take up to 15 full turns to load the brush.  Subsequent uses should require only 1 to 2 turns;  blend well until green tint disappears; after each use, wipe brush with a clean dry tissue and replace cap



    Adults and children 2 years of age and older     Apply to affected area not more than 3 to 4 times daily.

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

    Children under 2 years of age                          Ask a doctor


    Other Information
    do not use if package is torn, cut or otherwise damaged; store at 15-30C (59-86F) under dry conditions; this is a personal care item and should be used by one individual only

    Inactive ingredients
    caprylic/capric triglyceride, prunella vulgaris leaf extract, propylene glycol, water, tocopheryl acetate, retinyl palmitate, zea mays (corn) oil, tocopherol, cholecalciferol, titanium dioxide, yellow 5 lake, iron oxides, blue 1 lake


  • QUESTIONS

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


  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    ORAJEL FOR CODL SORES RELIEF AND CONCEALER 
    allantoin benzocaine camphor cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:10237-726
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 200 mg  in 1 g
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL) 30 mg  in 1 g
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN 5 mg  in 1 g
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 20 mg  in 1 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 10 mg  in 1 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 640 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PRUNELLA VULGARIS (UNII: ID3IB81B1C)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    CORN OIL (UNII: 8470G57WFM)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    IRON (UNII: E1UOL152H7)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:10237-726-05 1 in 1 BLISTER PACK
    1 1.4 g in 1 TUBE, WITH APPLICATOR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part356 07/19/2010
    Labeler - Church & Dwight Co., Inc. (001211952)
    Establishment
    Name Address ID/FEI Business Operations
    Direct Merchantdising Inc. 076693183 manufacture