Label: CVS ARNICA- arnica montana flower gel

  • NDC Code(s): 66902-778-26
  • Packager: Natural Essentials, Inc.
  • 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 January 27, 2021

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  • Active ingredient

    Arnica Montana 1X HPUS-7%

  • Purpose*

    Bruises & Muscle Soreness

  • Uses*

    Homeopathic remedy/medicine temporarily relieves muscle pain and stiffness due to minor injuries; reduces pain, swelling and discoloration from bruises.

  • Warnings

    For external use only

    When using this product

    Use only as directed

    • do not use with other topical products.
    • do not bandage tightly or use a heating pad.

    Stop use and ask a doctor If

    • a rash or other adverse reaction occurs.
    • symptoms worsen or persist for more than 7 days.
    • avoid contact with eyes or mucous membranes, damaged skin or wounds.
    • do not use if you are allergic to Arnica montana or to any of this product's inactive ingredients.

    If pregnant or breast feeding, ask a physician before use.

    Keep out of reach of children and pets, if swallowed, seek professional help and contact Poison Control Center right away.

  • Directions

    Adults and Children 12 years and older:

    • Apply & gently massage painful or bruised areas
    • Repeat as needed, no more than 4 times a day
    • Wash hands after each use with cold water
    • Store in a cool, dry area - close cap tight

    Children under 12: Ask your doctor.

  • Other information

    Active ingredients are HPUS and manufactured according to homeopathic principles.

  • Inactive ingredients

    Caprylyl Glycol, Carbomer, PEG-8 Dimethicone, Phenoxyethanol, SDA 40-2 Alcohol, Sodium Hydroxide, Water.

  • Principal Display Panel - 73 g Carton Label

    CVSHealth®

    Compare to the active ingredient
    in Arnicare® Gel**

    Arnica Gel

    RELIEF FOR PAIN, STIFFNESS & SWELLING*

    Homeopathic

    • Absorbs quickly
    • Unscented
    • Non-greasy
    • Paraben free

    Package Contains One Tube

    NET WT 2.6 OZ (73 g)

    *Claims based on traditional
    homeopathic practice, not accepted
    medical evidence. Not FDA evaluated.

    Principal Display Panel - 73 g Carton Label
  • Principal Display Panel - 73 g Tube Label

    CVS
    Health®

    Arnica Gel

    RELIEF FOR PAIN,
    STIFFNESS &
    SWELLING*

    Homeopathic

    • Absorbs quickly
    • Unscented
    • Non-greasy
    • Paraben free

    NET WT
    2.6 OZ
    (73 g)

    *Claims based on
    traditional homeopathic
    practice, not accepted
    medical evidence. Not
    FDA evaluated.

    Principal Display Panel - 73 g Tube Label
  • INGREDIENTS AND APPEARANCE
    CVS ARNICA 
    arnica montana flower gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66902-778
    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 73 g
    Inactive Ingredients
    Ingredient NameStrength
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALCOHOL (UNII: 3K9958V90M)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66902-778-261 in 1 CARTON01/27/2021
    173 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/27/2021
    Labeler - Natural Essentials, Inc. (947484713)
    Establishment
    NameAddressID/FEIBusiness Operations
    NATURAL ESSENTIALS, INC.947484713MANUFACTURE(66902-778)
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