Label: DOCTOR HOYS NATURAL ARNICA BOOST- hpus arnica montana cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated December 5, 2022

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

  • WARNINGS

    Warnings: for external use only, 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 or clear up and occur again within a few days, discontinue use of this product and consult a physician, Pregnancy-breast feeding warning: if pregnant or breast feeding, ask a health professional before use, do not bandage tightly

  • ACTIVE INGREDIENT

    Active Ingredients Purpose

    10% Arnica Montana 1X HPUS

  • INDICATIONS & USAGE

    Directions: Use by itself or with DOCTOR HOY'S Natural Pain Relief Gel. For adults and children 2 years and older. "Children under 2 years of age: consult a doctor." For best results, apply generously to affected and surrounding areas. Repeat as needed.

    Uses: for the temporary relief of minor aches and pains of muscles and joints due to: , inflammation, arthritis, sprains, strains, bruises

    Inactive Ingredients: deionized water, hamamelis virginiana (witch hazel extract), isopropyl alcohol, cetyl alcohol, glycerin, tocopheryl acetate (vitamin E), aloe vera, argan oil, calendula oil, chamomile, hyperium Perforatum Extract, safflower oil, tilia cordata flower extract

  • PURPOSE

    Uses: for the temporary relief of minor aches and pains of muscles and joints associated with: Inflammation, arthritis, sprains, strains, bruises, Expedites healing, Reduces swelling, Extends relief time, Absorbs quickly, Odorless

  • KEEP OUT OF REACH OF CHILDREN

    Warnings: for external use only, 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 or clear up and occur again within a few days, discontinue use of this product and consult a physician, Pregnancy-breast feeding warning: if pregnant or breast feeding, ask a health professional before use, do not bandage tightly

  • DOSAGE & ADMINISTRATION

    Directions: Use by itself or with DOCTOR HOY'S Natural Pain Relief Gel. for adults and children 2 years and older. "Children under 2 years of age: consult a doctor." For best results, apply generously to affected and surrounding areas. Repeat as needed.

  • PRINCIPAL DISPLAY PANEL

    An image/graphic of the product is included

    6oz HPUS Arnica

  • INGREDIENTS AND APPEARANCE
    DOCTOR HOYS NATURAL ARNICA BOOST 
    hpus arnica montana cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10842-203
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA WHOLE - UNII:O80TY208ZW) ARNICA MONTANA5 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CHAMOMILE (UNII: FGL3685T2X)  
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB)  
    .ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    JOJOBA OIL (UNII: 724GKU717M)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10842-203-02946 mL in 1 JUG; Type 0: Not a Combination Product06/20/2019
    2NDC:10842-203-0189 mL in 1 TUBE; Type 0: Not a Combination Product06/20/2019
    3NDC:10842-203-031893 mL in 1 JUG; Type 0: Not a Combination Product06/20/2019
    4NDC:10842-203-046 mL in 1 PACKET; Type 0: Not a Combination Product06/20/2019
    5NDC:10842-203-06177 mL in 1 TUBE; Type 0: Not a Combination Product06/20/2019
    6NDC:10842-203-0889 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product06/20/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/20/2019
    Labeler - DOCTOR HOY'S, LLC (791882322)
    Establishment
    NameAddressID/FEIBusiness Operations
    Specialty Formulations and Manufacturing LLC003989912manufacture(10842-203) , label(10842-203)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dynamic Blending Specialists, Inc.085704438manufacture(10842-203)
    Establishment
    NameAddressID/FEIBusiness Operations
    United Laboratories Manufacturing, LLC807878116manufacture(10842-203) , label(10842-203)