Label: ARNICA RELIEF- arnica montana cream

  • NDC Code(s): 61727-112-02
  • Packager: Homeocare Laboratories
  • 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 21, 2018

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  • Active Ingredients:

    Arnica Montana 1x (HPUS) 7%

  • Purpose:

    As a topical aid for the relief of bruising, injuries, muscle aches, pain relief and pre-post surgically.

  • Keep out of the reach of children.

    Keep out of the reach of children.

  • Indications for Usage:

    As a topical aid for the relief of bruising, injuries, muscle aches, pain relief and pre-post surgically.

  • Warnings:

    For external use only. Ask a doctor before use if pregnant or breastfeeding. Keep out of the reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

  • Inactive Ingredients:

    Avocado Oil, Caprylyl Glycol, Cetyl Alcohol, Dimethicone, Dimethyl Taurate Copolymer, Glycerin USP, Glyceryl Stearate, Caprylic/Capric Triglyceride, Hexylen Glycol, Phenoxyethanol, Polyethylene, Sodium Polyacrylate, Potassium Sorbate, Purified Water, Sodium Acrylate/Sodium Acryloyl, Sunflower Oil.

  • Dosage & Administration:

    For external use only. Apply generously to affected area. 2 to 3 times daily or as needed. Rub gently until complete absorption. Safe for children over 2 years old (under 2 years ask a doctor).

  • Arnica Relief Cream

    Arnica Cream Front Pic.jpgArnica Cream Back Pic.jpg

  • INGREDIENTS AND APPEARANCE
    ARNICA RELIEF 
    arnica montana cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61727-112
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA1 [hp_X]  in 56.7 g
    Inactive Ingredients
    Ingredient NameStrength
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    TRICAPRIN (UNII: O1PB8EU98M)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM ACRYLATE (UNII: 7C98FKB43H)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61727-112-0256.7 g in 1 TUBE; Type 0: Not a Combination Product12/21/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/10/2012
    Labeler - Homeocare Laboratories (088248828)
    Registrant - Homeocare Laboratories (088248828)
    Establishment
    NameAddressID/FEIBusiness Operations
    Homeocare Laboratories088248828manufacture(61727-112)
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