Label: ROYAL KING PAIN RELIEF PATCH- camphor 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 November 29, 2021

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  • ACTIVE INGREDIENTS

    Camphor (Synthetic)     0.13%

  • PURPOSE

    Camphor (Synthetic)      Topical 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.

    This product may cause a rash on area of application.

  • 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 are hypersensitive to this product

    otherwise than as directed

  • ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE

    pregnant

    of irritated or damaged skin.

  • 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 the plaster to affected area after cleaning once a day. Remove after 12 hours.
    Reapply another one after 6 hours. Children under 12 years of age, consult a doctor. Children under 2 years of age: Do not use, consult a doctor.

  • OTHER INFORMATION

    Keep container tightly closed.

    Store below 20°C (68°F) in a dry area.

  • INACTIVE INGREDIENTS

    LANOLIN, LIGUSTICUM WALLICHII ROOT, CURCUMA ZEDOARIA LEAF, GARDENIA JASMINOIDES FLOWER, RHEUM OFFICINALE ROOT, ASPERAGENIN, PAWPAW, FRANKINCENSE, MYRRH

  • QUESTIONS OR COMMENTS

    Manufactured by Tianshui Weishi Tongtai Pharmaceutical Co, Ltd

    No.3 Road, Shetang Industry Park, Tianshui Economy & Technology Development Area, Tianshui City, Gansu Province, China 741024

    Distributed by Herba Natural Products, Inc.

    211 41st Street, Brooklyn, NY 11232

    Phone: (718)788-0222

  • DRUG FACTS

    image description

  • INGREDIENTS AND APPEARANCE
    ROYAL KING PAIN RELIEF PATCH 
    camphor patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69412-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.13 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    LANOLIN (UNII: 7EV65EAW6H)  
    LIGUSTICUM WALLICHII ROOT (UNII: R81AD159QS)  
    CURCUMA ZEDOARIA LEAF (UNII: M9E9LQH7N4)  
    GARDENIA JASMINOIDES FLOWER (UNII: 2TU49609L2)  
    RHEUM OFFICINALE ROOT (UNII: A47JP5ZG9M)  
    ASPERAGENIN (UNII: 56JLP9B53W)  
    PAWPAW (UNII: 8P95FP65YO)  
    FRANKINCENSE (UNII: R9XLF1R1WM)  
    MYRRH (UNII: JC71GJ1F3L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69412-001-033 in 1 BOX12/20/2016
    17.9 g in 1 PATCH; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/20/2016
    Labeler - Tianshui Weishi Tongtai Pharmaceutical Co Ltd (544305099)
    Registrant - Tianshui Weishi Tongtai Pharmaceutical Co Ltd (544305099)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tianshui Weishi Tongtai Pharmaceutical Co Ltd544305099manufacture(69412-001)
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