Label: DOUBLE PRAWN BRAND HERBAL OIL- menthol oil

  • NDC Code(s): 14720-372-29, 14720-372-30
  • Packager: Tai Tong Ah Co Pte Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 11/13

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  • ACTIVE INGREDIENTS

    Menthol 3.5%

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  • PURPOSE

    Menthol   External Analgesic

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  • 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.

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  • 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.

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  • WARNING

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

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  • WARNING

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

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  • DIRECTIONS

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

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  • DIRECTIONS

    Apply Herbal Oil several times daily.

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  • STORAGE

    Store at cool and dry place from direct sunlight.

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  • INACTIVE INGREDIENT

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

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  • DRUG FACTS
  • INGREDIENTS AND APPEARANCE
    DOUBLE PRAWN BRAND HERBAL OIL 
    benzocaine, menthol oil
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:14720-372
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (MENTHOL) MENTHOL 3.5 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    CAMPHOR (SYNTHETIC)  
    DICTAMNUS DASYCARPUS WHOLE  
    COMMIPHORA MYRRHA WHOLE  
    SOPHORA FLAVESCENS WHOLE  
    SANGUISORBA OFFICINALIS WHOLE  
    GLEDITSIA SINENSIS WHOLE  
    RHEUM PALMATUM WHOLE  
    Product Characteristics
    Color white Score     
    Shape ROUND Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:14720-372-30 1 in 1 CARTON
    1 NDC:14720-372-29 28 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part346 12/27/2004
    Labeler - Tai Tong Ah Co Pte Ltd (595198821)
    Registrant - Tai Tong Ah Co Pte Ltd (595198821)
    Establishment
    Name Address ID/FEI Business Operations
    Tai Tong Ah Co Pte Ltd 595198821 manufacture(14720-372)
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