Label: DOCTOR HOYS NATURAL PAIN RELIEF- menthol and camphor (natural) gel

  • NDC Code(s): 10842-212-01, 10842-212-02
  • Packager: DOCTOR HOY'S, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 12/14

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

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS:          
    CAMPHOR (5%)                       

    MENTHOL (5%)                        

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  • Purpose

    TOPICAL ANALGESIC

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  • INDICATIONS & USAGE

    USES:

    TEMPORARY RELIEF OF MINOR ACHES AND PAINS OF MUSCLES AND JOINTS DUE TO

    • BACKACHE
    • ARTHRITIS
    • SPRAINS
    • STRAINS
    • BRUISES
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  • WARNINGS

    WARNINGS

    • FOR EXTERNAL USE ONLY
    • DO NOT APPLY TO OPEN INJURIES OR DAMAGED SKIN
    • DO NOT BANDAGE TIGHTLY
    • DO NOT USE WITH A HEATING PAD
    • AVOID CONTACT WITH EYES
    • KEEP OUT OF REACH OF CHILDREN
    • IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY
    • IF CONDITION WORSENS, OR IF SYMPTOMS PERSIST FOR MORE THAN 7 DAYS, DISCONTINUE USE OF THIS PRODUCT AND CONSULT A PHYSICIAN.
    • PREGNANCY-BREAST FEEDING WARNING:  IF PREGNANT OR BREAST FEEDING, AS A HEALTH PROFESSIONAL BEFORE USE.

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  • DOSAGE & ADMINISTRATION

    DIRECTIONS

    • FOR BEST RESULTS, APPLY GENEROUSLY TO AFFECTED AND SURROUNDING AREAS
    • USE 1 LAYER FOR MINOR PAIN, 2 FOR MEDIUM AND 3 LAYERS FOR SEVERE SYMPTOMS
    • RUB IN WELL AND ALLOW TO DRY BETWEEN LAYERS (USUALLY 2-3 MINUTES)
    • REPEAT PROCESS UP TO 4 TIMES DAILY
    • FOR ADULTS AND CHILDREN 2 YEARS AND OLDER
    • FOR CHILDREN UNDER 2 YEARS OF AGE, CONSULT A DOCTOR
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  • INACTIVE INGREDIENTS

    ARNICA MONTANA FLOWER EXTRACT, HAMAMELIS VIRGINIANA (WITCH HAZEL) WATER,  WATER, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, BIOSACCHARIDE GUM-1, BUTYROSPERMUM PARKII (SHEA BUTTER) FRUIT,  CELLULOSE, ALCOHOL, ETHYLHEXYLGLYCERIN, EUPHORBIA CERIFERA (CANDELILLA) WAX, GLYCERIN, HYDROLYZED SILICA, HYDROXYPROPYL METHYLCELLULOSE, LACTOSE, PHENOXYETHANOL, OLEYL ALCOHOL, POLYSORBATE 20, SD ALCOHOL 40-B, SODIUM STARCH OCTNYLSUCCINATE, TOCOPHERYL ACETATE, ZANTHOXYLUM BUNGEANUM FRUIT EXTRACT, CHROMIUM HYDROXIDE GREEN

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  • HOW SUPPLIED

    Distributed by : DOCTOR HOY'S, LLC MESA, AZ 85209

    (866) 674-8000   www.drhoys.com

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  • INGREDIENTS AND APPEARANCE
    DOCTOR HOYS NATURAL PAIN RELIEF 
    camphor menthol gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:10842-212
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (MENTHOL) MENTHOL 5.00 g  in 100 mL
    CAMPHOR (NATURAL) (CAMPHOR (NATURAL)) CAMPHOR (NATURAL) 5.00 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    HAMAMELIS VIRGINIANA TOP WATER  
    ALCOHOL  
    GLYCERIN  
    PHENOXYETHANOL  
    ETHYLHEXYLGLYCERIN  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER  
    CANDELILLA WAX  
    HYDRATED SILICA  
    SHEA BUTTER  
    BIOSACCHARIDE GUM-1  
    OLEYL ALCOHOL  
    ZANTHOXYLUM BUNGEANUM FRUIT  
    POLYSORBATE 20  
    ARNICA MONTANA FLOWER  
    LACTOSE  
    POWDERED CELLULOSE  
    .ALPHA.-TOCOPHEROL ACETATE  
    HYPROMELLOSES  
    CHROMIUM HYDROXIDE GREEN  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:10842-212-01 119.0 mL in 1 TUBE
    2 NDC:10842-212-02 3.5 mL in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part356 07/01/2012
    Labeler - DOCTOR HOY'S, LLC (791882322)
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