Label: SIERRASIL PAIN RELIEF- camphor spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 May 25, 2010

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  • ACTIVE INGREDIENT

    Camphor (3.1%)

  • PURPOSE

    External analgesic

  • INDICATIONS & USAGE

    Uses:

    Temporarily relieves minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.

  • WARNINGS

    FOR EXTERNAL USE ONLY

  • DO NOT USE

    Do not use for arthritis-like conditions in children under 2

    Do not use with a heating pad

    Do not apply to wounds, damaged, broken or irritated skin

  • WHEN USING

    When using this product, use only as directed

    Do not bandage tightly

    Avoid contact with eyes and mucous membranes

  • ASK DOCTOR

    Stop and ask doctor if conditions worsens, symptoms last for more than 7 days, or symptoms clear up and come back in a few days

  • PREGNANCY OR BREAST FEEDING

    Pregnant women should consult their physician before use

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

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

  • DOSAGE & ADMINISTRATION

    Adults and children 2 yrs of age and older:  Apply to affected area not more than 3 to 4 times daily.

    Children under 2 yrs of age:  Do not use, consult a doctor.

  • INACTIVE INGREDIENT

    Aloe vera oil, Eucalyptus oil, Lavender oil, Lemon oil, Orange oil, Peppermint oil, Rosemary oil, and SierraSil

  • QUESTIONS

    Questions?

    Visit www.sierrasil.com or call toll free 1-877-743-7720

  • STORAGE AND HANDLING

    Shake well before use

  • PRINCIPAL DISPLAY PANEL

    Sierra Sil

    Pain Relief

    Health You Can Feel

    Temporarily relieves minor aches and pains



    Product of USA

    Manufactured under US patent number 6,444,238 B1 by Swiss Medica Inc.

    Distributed by SierraSil Health Inc., Vancouver, B.C. V6J 4Z6 Canada

    Sierra Sil Label

  • INGREDIENTS AND APPEARANCE
    SIERRASIL  PAIN RELIEF
    camphor spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50802-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR OIL (UNII: 75IZZ8Y727) (CAMPHOR OIL - UNII:75IZZ8Y727) CAMPHOR OIL1 mL  in 30 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50802-001-3030 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34803/01/2010
    Labeler - Sierra Mountain Minerals Inc. d/b/a Sierra Sil Health Inc. (829616213)
    Registrant - Sierra Mountain Minerals Inc. d/b/a Sierra Sil Health Inc. (829616213)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sierra Mountain Minerals Inc. d/b/a Sierra Sil Health Inc.829616213relabel
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