Label: BRAZMEDICS ARNICA CREAM cream

  • NDC Code(s): 61727-114-02
  • 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 July 6, 2018

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  • Active Ingredient:

    Arnica Montana 1X (HPUS) 7%

  • Purpose

    #1 First-aid Remedy for the relief of Bruises, Injuries, Muscle Aches, Pre/Post Surgery, Pain Relief

    Homeopathic Medicine

    PARABENS FREE

  • Keep out of the reach of children

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

  • 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

  • Directions:

    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 year old (under 2 years ask a doctor).

    When using this product: Do not get into eyes and do not apply on open skin. Stop use and ask a doctor if: Condition worsens, symptoms last more than 7 days, you are allergic to any of the ingredients.

  • Directions:

    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).

  • Brazmedics Arnica Front Label

    Brazmedics Arnica Cream Front Label.jpg

  • Brazmedics Arnica Cream Back Label

    Brazmedics Arnica Cream Back Label.jpg

  • INGREDIENTS AND APPEARANCE
    BRAZMEDICS ARNICA CREAM 
    brazmedics arnica cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61727-114
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA1 [hp_X]  in 1 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
    TRICAPRIN (UNII: O1PB8EU98M)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    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:61727-114-021 [hp_X] in 1 TUBE; Type 0: Not a Combination Product07/06/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/06/2018
    Labeler - Homeocare Laboratories (088248828)
    Registrant - Homeocare Laboratories (088248828)
    Establishment
    NameAddressID/FEIBusiness Operations
    Homeocare Laboratories088248828manufacture(61727-114)
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