ARNICA GEL- arnica montana gel

Arnica Gel by

Drug Labeling and Warnings

Arnica Gel by is a Homeopathic medication manufactured, distributed, or labeled by King Bio Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts__________________________________________________________________________________________________________

Active ingredient:

Arnica montana 1X HPUS*-7%

*HPUS indicates inclusion in the official Homeopathic Pharmacopoeia of the United States.

INDICATIONS & USAGE

Uses Temporarily relieves: swelling form minor injuries muscle pain and stiffness, and bruising, due to minor injuries or overexertion. †as per various materia medicas. Product "Uses" have not been evaluated by the FDA. Product has not been clinically tested.

WARNINGS

Warnings:

• For external use only. Avoid contact with eyes and broken skin.
• If pregnant or breast-feeding, ask a health professional before use.
• Nursing mothers should not apply to breast area.
• Keep out of reach of children.
• If swallowed, get medical help or contact a Poison Control Center immediately.
• Stop use and ask a doctor if: symptoms worsen or do not improve within 3 days skin irritation, redness or rash occurs.

KEEP OUT OF REACH OF CHILDREN

• Keep out of reach of children.

DOSAGE & ADMINISTRATION

Directions: Apply to affected areas 2 or 3 times daily, or more often as needed. For best results, apply at the onset of symptoms.

OTHER SAFETY INFORMATION

Other information:

• Do not use if carton or tube seal is broken.
• Store at 68-77°F (20-25°C).
• Keep carton for complete drug facts and product information.

INACTIVE INGREDIENT

Inactive ingredients:  Alcohol denat, carbomer, purified water, sodium hydroxide.

PURPOSE

Drug Facts

____________________________________________________________________________________________________________________

Active ingredients                                   Purpose†

Arnica montana.......................................Swelling from minor injuries, muscle pain and stiffness, bruising due to minor injuries or overexertion.

*HPUS indicates inclusion in the official Homeopathic Pharmacopoeia of the United States.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ARNICA GEL 
arnica montana gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57955-3203
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 73 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57955-3203-3	1 in 1 CARTON
1		73 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		03/07/2016

Labeler - King Bio Inc. (617901350)

Registrant - King Bio Inc. (617901350)

Establishment
Name	Address	ID/FEI	Business Operations
King Bio Inc.		617901350	manufacture(57955-3203)