SOOTHING ADVANCED ARNICA- arnica montana, arnica montana, radix cream

Soothing Advanced Arnica by

Drug Labeling and Warnings

Soothing Advanced Arnica by is a Homeopathic medication manufactured, distributed, or labeled by King Bio Inc., Medical Products Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts__________________________________________________________________________________________________________

HPUS active ingredients: Arnica montana, Arnica montana, radix. Equal volumes of each active ingredient in 6X, 30X, 6C, 30C, and LM1 potencies. Active ingredients 50% of total weight.       

INDICATIONS & USAGE

Uses for temporary relief of symptoms: stiff muscles or joints inflammation bruising and discoloration

soreness after exercise.

WARNINGS

Warnings

• For external use only. Avoid contact with eyes and broken skin.
• Stop use and ask a doctor if symptoms worsen or do not improve within 7 days. skin irritation, redness or rash occurs.
• 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.

KEEP OUT OF REACH OF CHILDREN

• Keep out of reach of children.

DOSAGE & ADMINISTRATION

Directions

Shake before using. Apply generously to affected areas 2 to 3 times daily, or more often as needed. Massage in thoroughly until absorbed. For best results, apply immediately after the onset of symptoms. Reapply after bathing and before bedtime for ongoing relief. May be used before and after exercise.

OTHER SAFETY INFORMATION

Other information:

• To open: unscrew cap, remove tube seal, replace cap.
• Safety sealed for your protection.
• Do not use if tube seal is missing.
• Store at 68-77° (20-25°C).

INACTIVE INGREDIENT

Inactive ingredients: Cetearyl alcohol, deionized water, glyceryl stearate, jojoba seed oil, lemon oil, phenoxyethanol, pomegranate fruit extract, shea butter, sodium lactate, sodium stearoyl lactylate, sweet almond oil.

PURPOSE

Uses for temporary relief of symptoms:

• stiff muscles or joints
• inflammation
• bruising and discoloration
• soreness after exercise

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SOOTHING ADVANCED ARNICA 
arnica montana, arnica montana, radix cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57955-7301
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	6 [hp_X]  in 85 g
ARNICA MONTANA ROOT (UNII: MUE8Y11327) (ARNICA MONTANA ROOT - UNII:MUE8Y11327)	ARNICA MONTANA ROOT	6 [hp_X]  in 85 g

Inactive Ingredients
Ingredient Name	Strength
ARNICA CHAMISSONIS FLOWER (UNII: 88WK5I8R3L)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
WATER (UNII: 059QF0KO0R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
JOJOBA OIL (UNII: 724GKU717M)
LEMON OIL (UNII: I9GRO824LL)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POMEGRANATE (UNII: 56687D1Z4D)
SHEA BUTTER (UNII: K49155WL9Y)
SODIUM LACTATE (UNII: TU7HW0W0QT)
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)
ALMOND OIL (UNII: 66YXD4DKO9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57955-7301-3	85 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		05/07/2014

Labeler - King Bio Inc. (617901350)

Registrant - King Bio Inc. (617901350)

Establishment
Name	Address	ID/FEI	Business Operations
Medical Products Laboratories, Inc.		002290302	api manufacture(57955-7301)