ZHENWEILONG HUOLUO YOU EXTERNAL ANALGESIC (CAMPHOR MENTHOL METHYL SALICYLATE) OIL [UNCLE BILL TRADING USA INC.]

ZHENWEILONG HUOLUO YOU EXTERNAL ANALGESIC (CAMPHOR MENTHOL METHYL SALICYLATE) OIL [UNCLE BILL TRADING USA INC.]
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NDC 49952-001-01, 49952-001-50
Set ID 379fbe7f-c9b3-4ccf-88a6-e8361a08721f
Category HUMAN OTC DRUG LABEL
Packager Uncle Bill Trading USA Inc.
Generic Name
Product Class
Product Number
Application Number PART348
  • Active Ingredients

    Camphor 10%

    Menthol 15%

    Methyl Salicylate 30%

  • Purpose

    external analgesic

    external analgesic

    external analgesic

  • Uses

    For the temporary relief of minor aches and pains of muscles and joints associated with:

    ■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains

  • Warnings

    For external use only

    ■ Avoid getting into the eyes or on mucous membranes

    ■ Discontinue use if excessive irritation of the skin develops

  • When using this product

    ■ Do not apply to wound or damaged skin.

    ■ Do not bandage tightly

  • Stop use and ask a doctor if

    ■ Condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

    ■ Pain persists for more than 10 days conditions ■ Redness is present ■ Conditions affect children under 12 years of age

  • Keep out of reach of children

    to avoid accidental poisoning. If swallowed, get medical help or contact a poison control center right away.

  • Directions

    ■ Adults and children 12 years of age and older apply to affected area not more than 3 to 4 time daily.

    ■ Children under 12 years of age, consult a doctor before using

    ■ Do not use otherwise than as directed

  • Inactive ingredients

    Dragon's blood (resin), eucalyptus oil, mineral oil, peppermint oil

  • Package Label

    image description

  • INGREDIENTS AND APPEARANCE
    ZHENWEILONG HUOLUO YOU  EXTERNAL ANALGESIC
    camphor menthol methyl salicylate oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49952-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)10 g  in 100 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL15 g  in 100 mL
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE30 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    DRAGON'S BLOOD (UNII: M3YJ2C28IC)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49952-001-011 in 1 BOX
    1NDC:49952-001-5050 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/01/2013
    Labeler - Uncle Bill Trading USA Inc. (795709307)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hong Kong Zihua Pharmaceutical Ltd.663989580manufacture(49952-001)

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