Label: ORAJEL COLD SORE MOISTURELOCK- benzocaine cream

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

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 January 13, 2022

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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 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 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 not finalpart35607/01/2016
    Labeler - Church & Dwight Co., Inc. (001211952)
    Establishment
    NameAddressID/FEIBusiness Operations
    Accupac071609663manufacture(10237-761)
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