Label: ORAJEL COLD SORE MOISTURELOCK- benzocaine cream

  • NDC Code(s): 10237-761-01
  • Packager: Church & Dwight Co., Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 26, 2024

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  • ACTIVE INGREDIENT

    Allantoin 0.5%

    Benzocaine 20%

    Camphor 3%

    Dimethicone 2%

    Menthol 1%

    White petrolatum 64%

  • PURPOSE

    Allantoin - Skin protectant

    Benzocaine - Topical anesthetic

    Camphor - Topical analgesic

    Dimethicone - Skin protectant

    Menthol - Topical analgesic

    White petrolatum - Skin protectant

  • INDICATIONS & USAGE

    Uses •temporarily relieves pain and dryness; softens crusts (scabs) associated with • cold sores • fever blisters

  • WARNINGS

    For external use only.

    Allergy alert:do not use if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics

  • DO NOT USE

    Do not use •more than directed • for more than 7 days unless directed by a physician

  • WHEN USING

    When using this product• do not get into eyes

  • STOP USE

    Stop use and ask a physician if• conditions worsens • symptoms do not improve in 7 days • symptoms clear up and occur again within a few 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 Poison Control Center right away.

  • Directions

    • squeeze tube to dispense • blend well until green tint disappears • rub in gently

    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 physician

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

  • INACTIVE INGREDIENT

    Inactive Ingredientscaprylic/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 commentscall us at 800 952 5080 Monday through Friday 9 to 5 ET or visit www orajel com

  • PRINCIPAL DISPLAY PANEL

    Orajel

    Instan Pain Relief

    FOR COLD SORES

    MOISTURELOCK FORMULA

    Helps Speed Healing

    Treats 6 Symptoms:

    1 Pain

    2 Itching

    3 Redness

    4 Scabbing

    5 Cracking

    6 Dryness

    PLUS

    Helps Minimize Appearance of Cold Sores

    Topical Anesthetic/Topical

    Analgesic/Skin Protectant

    NET WT 0.105 OZ (3g)

    FT_OJBC-99882-04

    BK_OJBC-99882-04

  • INGREDIENTS AND APPEARANCE
    ORAJEL COLD SORE MOISTURELOCK 
    benzocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-761
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 g
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN5 mg  in 1 g
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)30 mg  in 1 g
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE20 mg  in 1 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 mg  in 1 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM640 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PRUNELLA VULGARIS LEAF (UNII: 2LW0610U4O)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    CORN OIL (UNII: 8470G57WFM)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Product Characteristics
    ColorgreenScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10237-761-011 in 1 CARTON07/01/2016
    13 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01607/01/2016
    Labeler - Church & Dwight Co., Inc. (001211952)
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