BRAZMEDICS ARNICA CREAM cream

BRAZMEDICS ARNICA Cream by

Drug Labeling and Warnings

BRAZMEDICS ARNICA Cream by is a Homeopathic medication manufactured, distributed, or labeled by Homeocare Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 Back Label

INGREDIENTS AND APPEARANCE

BRAZMEDICS ARNICA CREAM 
brazmedics arnica cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61727-114
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	1 [hp_X]  in 1 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61727-114-02	1 [hp_X] in 1 TUBE; Type 0: Not a Combination Product	07/06/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		07/06/2018

Labeler - Homeocare Laboratories (088248828)

Registrant - Homeocare Laboratories (088248828)

Establishment
Name	Address	ID/FEI	Business Operations
Homeocare Laboratories		088248828	manufacture(61727-114)