KATINKO PAIN AND ITCH RELIEVING (CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE) OINTMENT [GREENSTONE PHARMACEUTICAL H.K. INC.]

KATINKO PAIN AND ITCH RELIEVING (CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE) OINTMENT [GREENSTONE PHARMACEUTICAL H.K. INC.]
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NDC 52241-100-03, 52241-100-10, 52241-100-30
Set ID fe907fa4-4a01-4974-b71f-9cd980b4eaa2
Category HUMAN OTC DRUG LABEL
Packager Greenstone Pharmaceutical Inc.
Generic Name
Product Class
Product Number
Application Number PART348
  • ACTIVE INGREDIENT

    Active Ingredients:           

    Camphor 11 percent                 

    Menthol 7.6 percent                 

    Methyl Salicylate 13.0 percent  

  • Purpose

    Topical Analgesic

    Topical Analgesic

    Topical Analgesic

  • Uses:

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

    Simple Backache       Arthritis      Rheumatism      Muscle Strain      Sprains      Bruises

    For temporary relief of pain and itching associated with:

    Insect Bites      Minor skin irritation

  • WARNINGS

    Warnings

    For External Use Only.

  • WHEN USING

    When using this product:

    Use only as directed.

    Do not apply to wounds or damaged skin.

    Do not use on the eyes or on the mucous membranes.

    Do not use with a heating pad or apply external heat.

  • STOP USE

    Stop use and ask a doctor if:

    Skin redness or excessive irritation of the skin occurs

    Condition worsens

    Symptoms persists for more than 7 days or clears up and occurs again within a few days

    Do not bandage tightly

  • Keep out of reach of children

    If swallowed, get medical help or contact a poison control

  • DOSAGE & ADMINISTRATION

    Directions:

    Adults and children 2 yrs and up              Apply to affected areas not more than 3 to 4 times daily

    Children under 2 years                             Consult a doctor before use

  • Other Information

    This product make provoke allergic reaction in some individuals. Test on small area before use.

  • Inactive Ingredients

    Petroleum Jelly, Paraffin Wax

  • MANUFACTURED BY:

    Greenstone

    Pharmaceutical

    H.K. Inc.

    Anabu Industrial Estate,

    Imus, Cavite, Philippines 4103

    PRODUCT O F THE PHI L I P PI N E S

    MEDICATED

    For external use only

  • PRINCIPAL DISPLAY PANEL

    10g stickers10g box

  • 30g Package Label

    30g Label

  • INGREDIENTS AND APPEARANCE
    KATINKO PAIN AND ITCH RELIEVING 
    camphor (synthetic), menthol, methyl salicylate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52241-100
    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 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL7.6 g  in 100 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE13 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52241-100-101 in 1 CARTON05/24/2010
    110 g in 1 JAR; Type 0: Not a Combination Product
    2NDC:52241-100-031 in 1 CARTON05/24/2010
    23 g in 1 JAR; Type 0: Not a Combination Product
    3NDC:52241-100-301 in 1 CARTON05/24/2010
    330 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/24/2010
    Labeler - Greenstone Pharmaceutical Inc. (719794307)
    Registrant - Greenstone Pharmaceutical Inc. (719794307)
    Establishment
    NameAddressID/FEIBusiness Operations
    Greenstone Pharmaceutical Inc.719794307manufacture(52241-100)

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