ARNICA- arnica montana gel

ARNICA by

Drug Labeling and Warnings

ARNICA by is a Homeopathic medication manufactured, distributed, or labeled by CVS PHARMACY, HOMEOLAB USA INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient:

Arnica montana (Leopard's bane) 1X HPUS-7%

Purpose

Arnica montana (Leopard's bane) 1X HPUS-7%...............trauma, muscle pain and stiffness, swelling from injuries, discoloration from bruising

REFERENCES

The letters 'HPUS' indicate that the components in this product are officially monographed in the Homoeopathic Pharmacopoeia of the United States.

Uses

For relief of muscle pain and stiffness due to minor injuries, overexertion and falls. Reduces pain and swelling, as well as discoloration from bruising.

Warnings

For external use only.

Do not use if tube seal is broken.

When using this product avoid contact with eyes and open wounds.

Stop use and ask a doctor if condition persists for more than 3 days or worsens.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Apply a thin layer of Arnica Gel to affected area as soon as possible after minor injury. Repeat 3 times a day or as needed.

Other information

Store at 68-77°F (20-25°C)

Inactive ingredients

Purified water, isopropyl alcohol, glycerin, sodium hydroxide, carbomer

CARTON

INGREDIENTS AND APPEARANCE

ARNICA 
arnica montana gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-711
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
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CARBOMER 940 (UNII: 4Q93RCW27E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59779-711-01	1 in 1 CARTON
1		73 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/22/2014

Labeler - CVS PHARMACY (062312574)

Registrant - HOMEOLAB USA INC (202032533)

Establishment
Name	Address	ID/FEI	Business Operations
HOMEOLAB USA INC		202032533	manufacture(59779-711)