Label: THAI HERBAL BALM LEMON GRASS (menthol and camphor- synthetic ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 July 26, 2012

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  • SPL UNCLASSIFIED SECTION

    Thai Herbal Balm Lemon Grass

  • Ingredients

    Active Ingredients
    		Purpose
    Menthol 10%
    		Topical analgesic
    Methyl Salicylate 12%
    		Topical analgesic
  • Use(s)

    For sore muscles and over-exertion.

    Provides sooting relief for aches and pains due to:

    • Backaches
    • Arthritis
    • Joint Pains
    • Stiffness
    • Sprains
    • Over-exertion
  • Directions

    • Adults and children 12 years of age and older : Apply Thai Herbal Balm Lemon Grass to affected area. Rub well on the affected area. Repeat 3 to 4 times daily.
    • Children under 12 years of age: ask a doctor before use.
  • Warnings

    For external use only

    Do not use

    • on wounds or damaged skin
    • with a heating pad
    • on a child under 12 years of age with arthritis-like conditions.

    Ask a doctor before

    use if you have redness over the affected area.

    When using this product

    • Avoid contact with the eyes or mucous membranes
    • Do not bandage tightly

    Stop use and ask a doctor if

    • Condition worsens or symptoms persist for more than 7 days
    • Symptoms clear up and occur again within a few days
    • Excessive skin irritation occurs

    Keep out of reach of children to avoid accidental ingestion.

    If swallowed, get medical help or contact a Poison Control Center immediately.

  • Other Information

    • This product may cause an allergic reaction in some individuals. Test on a small area before use.
  • Inactive Ingredients

    Peppermint Oil, Camphor And Paraffin Petrolatum.

  • PRINCIPAL DISPLAY PANEL - 50g Jar

    THAI HERBAL BALM

    LEMON GRASS

    PAIN RELIEVING OINTMENT

    NET WT. 1.75 oz. (50g)

    PRINCIPAL DISPLAY PANEL - 50g Jar

  • INGREDIENTS AND APPEARANCE
    THAI HERBAL BALM LEMON GRASS  
    menthol and camphor (synthetic) ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75978-3048
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol5 g  in 50 g
    Methyl Salicylate (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) Methyl Salicylate6 g  in 50 g
    Inactive Ingredients
    Ingredient NameStrength
    West Indian Lemongrass Oil (UNII: 5BIA40E9ED) 2.5 g  in 50 g
    Peppermint Oil (UNII: AV092KU4JH) 2.5 g  in 50 g
    Camphor (synthetic) (UNII: 5TJD82A1ET) 1.5 g  in 50 g
    Paraffin (UNII: I9O0E3H2ZE) 7.5 g  in 50 g
    Petrolatum (UNII: 4T6H12BN9U) 27.5 g  in 50 g
    Product Characteristics
    Colorwhite (white cream) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75978-3048-11 in 1 BOX
    150 g in 1 JAR
    2NDC:75978-3048-21 in 1 BOTTLE
    220 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/09/2007
    Labeler - Thai Herb and Spa (195629303)
    Establishment
    NameAddressID/FEIBusiness Operations
    THANYAPORN HERBS CO.,LTD.660966151manufacture(75978-3048)
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