Label: ZIHUA EMBROCATION COOLING PAIN RELIEF- camphor menthol methyl salicylate oil

  • 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 April 21, 2014

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  • 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:49952-004
    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:49952-004-011 in 1 BOX
    1NDC:49952-004-2626 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/15/2014
    Labeler - Uncle Bill Trading USA Inc. (795709307)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hong Kong Zihua Pharmaceutical Ltd.663989580manufacture(49952-004)
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