ARNICA by Rxhomeo Private Limited d.b.a. Rxhomeo, Inc ARNICA gel

ARNICA by

Drug Labeling and Warnings

ARNICA by is a Homeopathic medication manufactured, distributed, or labeled by Rxhomeo Private Limited d.b.a. Rxhomeo, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ARNICA GEL TINC HPUS

USES

Sprains, muscular pains and traumatic injuries

INDICATIONS

Condition listed above or as directed by the physician

DOSAGE & ADMINISTRATION SECTION

Apply a thin layer of Gel to the affected area, repeat 3 times a day or as needed.

WARNINGS

This product is to be used for self-limiting conditions

If symptoms do not improve in 4 days, or worsen, discontinue use and seek assistance of health professional

As with any drug, if you are preganant, or nursing a baby, seek professional advice before taking this product

Keep this and all medication out of reach of children

Do not use if capseal is broken or missing.
Close the cap tightly after use.

INACTIVE INGREDIENTS

ALOE VERA GEL

STORAGE

Store in a cool dark place

QUESTIONS OR COMMENTS

www.Rxhomeo.com | 1.888.2796642 | info@rxhomeo.com

Rxhomeo, Inc 9415 Burnet Road, Suite 312, Austin, TX 78758

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ARNICA 
arnica gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 15631-2305
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 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 15631-2305-0	1 in 1 CONTAINER	03/30/2016
1		50 g in 1 CONTAINER; Type 0: Not a Combination Product
2	NDC: 15631-2305-1	1 in 1 CONTAINER	03/30/2016
2		100 g in 1 CONTAINER; Type 0: Not a Combination Product
3	NDC: 15631-2305-2	1 in 1 CONTAINER	03/30/2016
3		200 g in 1 CONTAINER; Type 0: Not a Combination Product
4	NDC: 15631-2305-3	1 in 1 CONTAINER	03/30/2016
4		500 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		03/30/2016

Labeler - Rxhomeo Private Limited d.b.a. Rxhomeo, Inc (650833994)

Establishment
Name	Address	ID/FEI	Business Operations
Rxhomeo Private Limited d.b.a. Rxhomeo, Inc		650833994	manufacture(15631-2305) , label(15631-2305)