Label: DOUBLE PRAWN BRAND HERBAL OIL- benzocaine, menthol oil

  • 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 November 11, 2013

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  • ACTIVE INGREDIENTS

    Menthol 3.5%

  • PURPOSE

    Menthol   External Analgesic

  • USE

    For the relief from pain, swelling and itching due to skin irritation, skin infection, minor cuts, fungal infection, abrasions, bruises, minor burns and scalds, insect bites and a range of skin problems.

  • WARNING

    For external use only and use as directed. Avoid contact with eyes, mucous membrances or rashes, wounds or damage skin. Do not use with a heated pad.

  • WARNING

    Keep out of reach of children. If swallowed, get medical help immediately.

  • WARNING

    Stop use and consult a doctor if excessive irritaion of the skin develops. For children under 2 years of age, consult a doctor.

  • DIRECTIONS

    Apply Herbal Oil to the affective area several times; use cotton dressing if necessary, repeat several times until completely healed.

  • DIRECTIONS

    Apply Herbal Oil several times daily.

  • STORAGE

    Store at cool and dry place from direct sunlight.

  • INACTIVE INGREDIENT

    Camphor, dictampus dasycarpus, commiphora myrrha, sophora flavescens, sanguisorba officinalis, gleditsia sinensis, rheum palamatum

  • DRUG FACTS

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  • INGREDIENTS AND APPEARANCE
    DOUBLE PRAWN BRAND HERBAL OIL 
    benzocaine, menthol oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14720-372
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    DICTAMNUS DASYCARPUS WHOLE (UNII: IM7ZCU30YH)  
    COMMIPHORA MYRRHA WHOLE (UNII: UU81N77RI7)  
    SOPHORA FLAVESCENS WHOLE (UNII: X8KX602M5L)  
    SANGUISORBA OFFICINALIS WHOLE (UNII: J578M57Q8Z)  
    GLEDITSIA SINENSIS WHOLE (UNII: FS3UB95UTG)  
    RHEUM PALMATUM WHOLE (UNII: 75P857ARCY)  
    Product Characteristics
    ColorwhiteScore    
    ShapeROUNDSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14720-372-301 in 1 CARTON
    1NDC:14720-372-2928 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34612/27/2004
    Labeler - Tai Tong Ah Co Pte Ltd (595198821)
    Registrant - Tai Tong Ah Co Pte Ltd (595198821)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tai Tong Ah Co Pte Ltd595198821manufacture(14720-372)
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