ULTRA BALM (MENTHOL AND METHYL SALICYLATE) OINTMENT [LING NAM MEDICINE FACTORY (H.K.) LTD.]

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ULTRA BALM (MENTHOL AND METHYL SALICYLATE) OINTMENT [LING NAM MEDICINE FACTORY (H.K.) LTD.]
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NDC 57598-888-07, 57598-888-23, 57598-888-25
Set ID de997baf-aa04-474e-b912-3fc67e720d0b
Category HUMAN OTC DRUG LABEL
Packager Ling Nam Medicine Factory (H.K.) Ltd.
Generic Name
Product Class
Product Number
Application Number PART348
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Menthol 14%Topical analgesic
    Methyl Salicylate 23.2%Topical analgesic
  • Uses

    for temporary relief of minor aches and pains of muscles and joints associated with

    • simple backache
    • arthritis
    • strains
    • bruises
    • sprains
  • Warnings

    For external use only

    Do not use

    • If prone to allergic reaction from aspirin or salicylates

    When using this product

    • avoid contact with eyes or mucous membranes
    • do not apply to wounds, damaged or irritated skin
    • do not bandage tightly or use with heating pad
    • do not use 1 hour prior to bathing or 30 minutes after bathing

    Stop use and ask a doctor if

    • condition worsens
    • skin irritation or redness develops
    • pain persists for more than 7 days
    • clear up and occur again within a few days

    If pregnant or breastfeeding, ask health professional before use.

    Keep out of reach of children to avoid accidental poisoning. If swallowed, get medical help or contact Poison Control Center right away. Do not use otherwise than as directed.

  • Directions

    • for adults and children 12 years of age and over, apply to affected area not more than 3 to 4 times daily
    • for children 12 years or younger, consult a doctor before use
    • not intended for children under two years of age
  • Other information

    Close cap tightly after use. Store in cool place.

  • Inactive ingredients

    Eucalyptus Oil, Lanolin, Paraffin, Petroleum Jelly and Thyme Oil

  • Questions or comments?

    Please call 1-626-823-9933.

  • PRINCIPAL DISPLAY PANEL - 19.8 g Jar Carton

    NDC.No : 57598-888-07

    ULTRA BALM

    LING NAM®
    EXTERNAL ANALGESIC

    COOLING
    PAIN
    RELIEF

    Ling Nam Medicine Factory (H.K.) Limited
    Tuen Mun, New Territories, Hong Kong, China
    U.S.A. Sole Distributor: TCM Herbalway Inc.
    Covina, CA 91724 U.S.A.
    www.tcmherbalway.com

    Made in China
    Net Wt.0.7 oz (19.8g)

    PRINCIPAL DISPLAY PANEL - 19.8 g Jar Carton
  • PRINCIPAL DISPLAY PANEL - 65.1 g Jar Carton

    NDC.No : 57598-888-23

    ULTRA BALM

    LING NAM®
    EXTERNAL ANALGESIC

    COOLING
    PAIN
    RELIEF

    Ling Nam Medicine Factory (H.K.) Limited
    Tuen Mun, New Territories, Hong Kong, China

    Made in China
    Net Wt.2.3 oz (65.1g)

    PRINCIPAL DISPLAY PANEL - 65.1 g Jar Carton
  • INGREDIENTS AND APPEARANCE
    ULTRA BALM 
    menthol and methyl salicylate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57598-888
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol, Unspecified Form (UNII: L7T10EIP3A) (Menthol, Unspecified Form - UNII:L7T10EIP3A) Menthol, Unspecified Form140 mg  in 1 g
    Methyl Salicylate (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) Methyl Salicylate232 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Eucalyptus Oil (UNII: 2R04ONI662)  
    Lanolin (UNII: 7EV65EAW6H)  
    Paraffin (UNII: I9O0E3H2ZE)  
    Petrolatum (UNII: 4T6H12BN9U)  
    Thyme Oil (UNII: 2UK410MY6B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57598-888-251 in 1 CARTON08/01/201309/19/2017
    170.8 g in 1 JAR; Type 0: Not a Combination Product
    2NDC:57598-888-071 in 1 CARTON08/01/2013
    219.8 g in 1 JAR; Type 0: Not a Combination Product
    3NDC:57598-888-231 in 1 CARTON09/19/2017
    365.1 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34808/01/2013
    Labeler - Ling Nam Medicine Factory (H.K.) Ltd. (667152748)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ling Nam Medicine Factory (H.K.) Ltd.667152748MANUFACTURE(57598-888)
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