ZIHUA EMBROCATION COOLING PAIN RELIEF (CAMPHOR MENTHOL METHYL SALICYLATE) OIL [HONG KONG ZIHUA PHARMACEUTICAL LTD.]

ZIHUA EMBROCATION COOLING PAIN RELIEF (CAMPHOR MENTHOL METHYL SALICYLATE) OIL [HONG KONG ZIHUA PHARMACEUTICAL LTD.]
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NDC 49980-003-01, 49980-003-26
Set ID e1480d87-61ff-4af2-b362-6fe74c636b63
Category HUMAN OTC DRUG LABEL
Packager Hong Kong Zihua Pharmaceutical Ltd.
Generic Name
Product Class
Product Number
Application Number PART348
  • Active Ingredients

    Camphor 11%

    Menthol 15%

    Methyl salicylate 15%

  • 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

    ■ Apply liberally and gently rub into affected area

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

    ■ Do not use otherwise than as directed

  • Inactive ingredients

    Eucalyptus oil, FDC Blue No. 1 Al Lake, FDC Red No. 40 Al Lake, lavender oil, mineral oil

  • Package Label

    image description

  • INGREDIENTS AND APPEARANCE
    ZIHUA EMBROCATION  COOLING PAIN RELIEF
    camphor menthol methyl salicylate oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49980-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)11 g  in 100 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL15 g  in 100 mL
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE15 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49980-003-011 in 1 BOX
    1NDC:49980-003-2626 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/15/2014
    Labeler - Hong Kong Zihua Pharmaceutical Ltd. (663989580)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hong Kong Zihua Pharmaceutical Ltd.663989580manufacture(49980-003)

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