Label: RAMEDICA ointment

  • 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 February 20, 2014

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  • Active Ingredients

    Camphor

    Wintergreen Oil (Methyl Salicylate)

    Eucalyptus Oil

    Menthol

  • Purpose

    Topical Analgesic

  • Keep Out Of Reach Of Children

    If swallowed, get medical help or contact a Poison Control Center immediately.

  • Inactive Ingredients

    Borneol

    Cassia Oil

    Clove Oil

    Cinnamon Leaf Oil

    Citronella Oil

    Nutmeg Oil

    Petrolatum USP

  • Directions

    For adults and children over 12, rub well on the affected area. Repeat 3 to 4 times daily

    For children 12 years of age or younger, consult a doctor before use.

  • Warnings

    For external use only. This product may cause allergic reaction in some individuals. Test on small area before use.

  • Uses

    For temporary relief of the minor aches and pains in muscles and joints related to rheumatism, arthritis, backaches, strains, sprains, sports and other minor injuries.

  • Container Label

    Image of Container Label

  • INGREDIENTS AND APPEARANCE
    RAMEDICA 
    ramedica ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66059-0001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)2.53 g  in 1 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE2.30 g  in 1 g
    EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL2.30 g  in 1 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.84 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BORNEOL (UNII: M89NIB437X) 1 g  in 1 g
    PADANG CASSIA OIL (UNII: 0E15252LIW) 1 g  in 1 g
    CLOVE OIL (UNII: 578389D6D0) 1 g  in 1 g
    CINNAMON LEAF OIL (UNII: S92U8SQ71V) 1 g  in 1 g
    CITRONELLA OIL (UNII: QYO8Q067D0) 1 g  in 1 g
    NUTMEG OIL (UNII: Z1CLM48948) 1 g  in 1 g
    PETROLATUM (UNII: 4T6H12BN9U) 8.03 g  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66059-0001-123 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/13/2000
    Labeler - Ramedicare Sdn. Bhd. (894194026)
    Registrant - Ramedicare Sdn. Bhd. (894194026)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ramedicare Sdn. Bhd.894194026manufacture(66059-0001)
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