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 19, 2021

If you are a consumer or patient please visit this version.

  • Active Ingredients

    Camphor

    Eucalyptus Oil

    Menthol

    Peppermint oil

  • Purpose

    Topical Analgesic

  • Keep Out Of Reach Of Children

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

  • Inactive Ingredients

    Borneol 1%
    Cassia Oil 1%
    Cinnamon Leaf Oil 6%
    Citronella Oil 6%
    Clove Oil, Nutmeg Oil 6%
    Paraffin Wax 17%
    Petroleum Jelly 21%

  • 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.

  • 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

    WARNINGS: For external use only. When using this product: Discontinue use if excessive irritation of the skin develops. Avoid contact with eyes and mucus membranes. Do not bandage tightly. Do not use with heating pad.

    Stop use and ask a doctor if:
    ▪ Condition worsens. ▪ Severe skin irritation occurs. ▪ Pain persists for more than seven days. ▪ Pain clears up and the recurs within a few days.

    If pregnant or breast-feeding, ask a health care professional before use.
    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control immediately.

  • 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

    Product label

  • INGREDIENTS AND APPEARANCE
    RAMEDICA 
    ramedica ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66059-0002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)12 g  in 100 g
    EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL7 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL11 g  in 100 g
    PEPPERMINT OIL (UNII: AV092KU4JH) (PEPPERMINT - UNII:V95R5KMY2B) PEPPERMINT OIL6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BORNEOL (UNII: M89NIB437X)  
    PADANG CASSIA OIL (UNII: 0E15252LIW)  
    CLOVE OIL (UNII: 578389D6D0)  
    CINNAMON LEAF OIL (UNII: S92U8SQ71V)  
    CITRONELLA OIL (UNII: QYO8Q067D0)  
    NUTMEG OIL (UNII: Z1CLM48948)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66059-0002-123 g in 1 BOTTLE; Type 0: Not a Combination Product01/23/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/23/2018
    Labeler - Ramedicare Sdn. Bhd. (894194026)
    Registrant - Ramedicare Sdn. Bhd. (894194026)