Label: STRIVE PAIN RELIEF- arnica montana flower and comfrey leaf 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 April 3, 2019

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientPurpose
    Arnica Montana 1X HPUS 7%Pain relief, swelling, discoloration from bruising
    Comfrey (Symphytum Officinale) 1X HPUS 5%Healing, Pain Relief
  • Uses

    • For the temporary relief of minor aches and pains of joint and muscle pain associated with arthritis, simple backache, strains and bruises.
  • Warnings

    For external use only

    Allergy Alert

    If prone to allergic reactions apply on small area, consult a doctor before use.

    When using this product

    • use only as directed
    • do not use on open wounds or broken skin.

    Stop use and ask doctor if

    • condition worsens
    • redness is present
    • irritation develops
    • symptoms persist for more than 7 days.

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Massage a thin layer into the skin over the affected area every 4 to 8 hours or as needed
  • Other information

    store at 20-25° C (68-77° F)

  • Inactive ingredients

    Aloe barbadensis (aloe vera) leaf extract, Carbomer, Carthamus Tinctorius (Safflower) Seed Oil, Cetyl Alcohol, Deionized Water, Dimethyl Sulfone, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Histamine Dihydrochloride, Olea Europaea (Olive) Oil, Phenoxyethanol and Ethylhexylglycerin, Salix Alba (Willow) bark extract, Tetrasodium EDTA, Triethanolamine, Whey (Milk Isolates).

  • PRINCIPAL DISPLAY PANEL - 56.6 g Jar Carton

    NDC XXXX-XXX-XX

    MADE IN
    USA

    strive
    Topical Homeopathic Preparation

    CREAM
    PAIN RELIEF

    Made with all natural active ingredients

    Arnica + Comfrey

    NET WT 2 OZ (56.6 g)

    Principal Display Panel - 56.6 g Jar Carton
  • INGREDIENTS AND APPEARANCE
    STRIVE PAIN RELIEF 
    arnica montana flower and comfrey leaf cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63374-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Arnica Montana Flower (UNII: OZ0E5Y15PZ) (Arnica Montana Flower - UNII:OZ0E5Y15PZ) Arnica Montana Flower1 [hp_X]  in 1 g
    Comfrey Leaf (UNII: DG4F8T839X) (Comfrey Leaf - UNII:DG4F8T839X) Comfrey Leaf1 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Glycerin (UNII: PDC6A3C0OX)  
    Safflower oil (UNII: 65UEH262IS)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Salix Alba Bark (UNII: 205MXS71H7)  
    Dimethyl Sulfone (UNII: 9H4PO4Z4FT)  
    GLUCOSAMINE SULFATE POTASSIUM CHLORIDE (UNII: 15VQ11I66N)  
    Water (UNII: 059QF0KO0R)  
    Histamine Dihydrochloride (UNII: 3POA0Q644U)  
    Carbomer Copolymer Type B (Allyl Pentaerythritol Crosslinked) (UNII: 809Y72KV36)  
    Trolamine (UNII: 9O3K93S3TK)  
    Whey (UNII: 8617Z5FMF6)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63374-002-011 in 1 CARTON04/15/2019
    156.6 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC04/15/2019
    Labeler - Steuart Custom Manufacturing (116952121)
    Establishment
    NameAddressID/FEIBusiness Operations
    Steuart Custom Manufacturing116952121MANUFACTURE(63374-002)