Label: DR.OH PATCH (camphor- natural patch

  • 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 August 25, 2011

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  • ACTIVE INGREDIENT

    Active ingredients: CAMPHOR (NATURAL) 1.42%, MENTHOL 0.8%

  • INACTIVE INGREDIENT

    Inactive ingredients:

    Eucalyptus globulus leaf oil, Thymol, castor oil, dodecanal, citronellol, geraniol, citronellal, cymbopogon nardus oil, benzophenone, phenoxybenzene, benzyl benzoate

  • PURPOSE

    Purpose:

    Topical analgesic

  • WARNINGS

    Warnings:

    For external use only.

  • WHEN USING

    When using this product
    - use only as directed.
    - do not bandage tightly or use with a heating pad.
    - do not use on irritated, wounded or damaged skin.
    - avoid contact with eye or mucous membranes.

  • DO NOT USE

    Do not use if

    - you are allergic to fragrance.
    - you have asthma.
    - you are pregnant or breast-feeding.

  • STOP USE

    Stop use if
    - condition worsens or symptoms persist for more than 7days.
    - redness is present.
    - irritation develops.

  • ASK DOCTOR

    Ask a doctor if
    - condition worsens or symptoms persist for more than 7days.
    - redness is present.
    - irritation develops.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children:

    If patch is swallowed, get medical help or contact poison control center immediately.

  • INDICATIONS & USAGE

    Indication and usage:

    Adults and children over 12 years
    - use only as directed.
    - do not use on children under 12 years of age.
    - use up to 8 hours, repeat once if necessary.
    - reseal pouch containing unused patches.

  • STORAGE AND HANDLING

    Storage:

    Store in a cool and dry location out of direct sunlight.

  • QUESTIONS

    Questions:

    Phone: 608-362-6915
    E-mail: drohpatch@gmail.com

  • PRINCIPAL DISPLAY PANEL

    Image of cello pack

  • DOSAGE & ADMINISTRATION

    Dosage and administration:

    Use up to 8 hours, repeat once if necessary.

  • INGREDIENTS AND APPEARANCE
    DR.OH PATCH 
    camphor (natural) patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76163-010
    Route of AdministrationCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)28.4 mg  in 2000 mg
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL16 mg  in 2000 mg
    Inactive Ingredients
    Ingredient NameStrength
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
    THYMOL (UNII: 3J50XA376E)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    GERANIOL (UNII: L837108USY)  
    CITRONELLAL (UNII: QB99VZZ7GZ)  
    CITRONELLA OIL (UNII: QYO8Q067D0)  
    BENZOPHENONE (UNII: 701M4TTV9O)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    ETHYL ACETATE (UNII: 76845O8NMZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76163-010-012000 mg in 1 CELLO PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/01/2011
    Labeler - YEPHARM (557803716)
    Registrant - YEPHARM (557803716)
    Establishment
    NameAddressID/FEIBusiness Operations
    YEPHARM557803716manufacture
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