BRAZMEDICS ARNICA CREAM- brazmedics arnica cream cream 
Homeocare Laboratories

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.

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BRAZMEDICS ARNICA Cream

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

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)

Revised: 7/2018
Document Id: 705a8d0d-61ea-149d-e053-2a91aa0a6689
Set id: 705a8d0d-61e9-149d-e053-2a91aa0a6689
Version: 1
Effective Time: 20180706
 
Homeocare Laboratories