Label: PAIN RELIEVING- camphor, menthol spray

  • 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 19, 2015

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  • Active Ingredients

    Camphor            11%
    Menthol              16%

  • Purpose

    Camphor      External Analgesic

    Menthol        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.

  • 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: two or three times daily, massage 5-10 minutes until the affected area gets heat.

    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

    MUSCONE, PANAX NOTOGINSENG WHOLE, CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES, ANGELICA DAHURICA LEAF, DRAGON'S BLOOD, REHMANNIA GLUTINOSA ROOT

  • Questions or Comments?

    E-mail: info@bjwellspring.com

    Website: www.bjspringwell.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 description

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEVING 
    camphor, menthol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42217-207
    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 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL16 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    MUSCONE (UNII: UPS3C6CV36)  
    PANAX NOTOGINSENG WHOLE (UNII: E7XOU43ESD)  
    CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)  
    ANGELICA DAHURICA LEAF (UNII: ONF5ZKM88G)  
    DRAGON'S BLOOD (UNII: M3YJ2C28IC)  
    REHMANNIA GLUTINOSA ROOT (UNII: 1BEM3U6LQQ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42217-207-561 in 1 BOX
    156 mL in 1 BOTTLE, SPRAY
    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(42217-207)
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