Label: JOINT ANALGESIC PLASTER- camphor plaster

  • 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 March 13, 2015

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  • ACTIVE INGREDIENTS

    Camphor  3%

  • PURPOSE

    Camphor             External Analgesic

  • USES

    For the temporary relief of minor aches and pains of muscles and joints due to:

    simple backache

    arthritis

    strains

    bruises

    sprains

  • WARNINGS

    For External Use only.

    Allergy Alert: This product contains natural rubber latex which may cause allergic reactions.

  • DO NOT USE

    on wounds

    on irritated or damaged skin

    if the appearance of this product has changed

    in excess of 12 hours

    if you have known hypersensitive to this product

    otherwise than as directed

  • ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE

    pregnant

    taking other medications

  • WHEN USING THIS PRODUCT

    avoid contact with the eye or mucous membranes

    do not bandage tightly

    supervise use by children

    use caution if prone to allergic reactions

  • STOP USE AND ASK A DOCTOR IF

    condition worsens

    symptoms persist for more than 7 days

    symptoms clear up and occur again within a few days

    excessive irritation of the skin develops

    when using for pain of arthritis

    pain persists for more than 10 days

    redness is present

    in conditions affecting children under 12 years of age

  • KEEP OUT OF REACH OF CHILDREN.

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

  • DIRECTIONS

    Adults and children 12 years of age and older: Apply one or two plasters to affected area once a day. Remove after 12 hours.
    Children 2 to 12 years of age and adults with compromised health: Use only under the guidance of a doctor.
    Children under 2 years of age: Do not use, consult a doctor.
    Refer to the above warnings: use otherwise than as directed may be dangerous.

  • OTHER INFORMATION

    Keep container tightly closed.

    Store below 20 ℃  (68 ℉) in a dry area.

  • INACTIVE INGREDIENTS

    PEPPERS, BELLADONNINE, PEPPERMINT OIL, METHYL SALICYLATE, NIACIN, DIPHENHYDRAMINE, NATURAL LATEX RUBBER, ROSIN, ZINC OXIDE, LANOLIN, PETROLATUM, PARAFFIN, ANTIOXIDANT 119

  • QUESTIONS OR COMMENTS?

    E-mail: info@bjwellspring.com

    Website: www.bjwellspring.com

  • Manufactured by

    Henan Lingrui Pharmaceutical Co.; Ltd.

    232 Xiang Yang Road, Xin County, Henan, China

    Beijing Lingrui Wellspring Imp. & Exp. Co.; Ltd.

    Overseas Exclusive Distribution

  • DRUG FACTS

    image

  • INGREDIENTS AND APPEARANCE
    JOINT ANALGESIC PLASTER 
    camphor plaster
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42217-205
    Route of AdministrationTRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PEPPERS (UNII: T5KDM4J239)  
    BELLADONNINE (UNII: 1DF50P9K2I)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    NIACIN (UNII: 2679MF687A)  
    DIPHENHYDRAMINE (UNII: 8GTS82S83M)  
    ROSIN (UNII: 88S87KL877)  
    NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    LANOLIN (UNII: 7EV65EAW6H)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    ANTIOXIDANT 119 (UNII: UBL01213LI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42217-205-1010 in 1 BOX
    11 g in 1 PATCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/02/2010
    Labeler - Henan Lingrui Pharmaceutical Co Ltd (530021062)
    Registrant - Henan Lingrui Pharmaceutical Co Ltd (530021062)
    Establishment
    NameAddressID/FEIBusiness Operations
    Henan Lingrui Pharmaceutical Co Ltd530021062manufacture(42217-205)
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