ARNICA- cvs arnica montana gel

ARNICA by

Drug Labeling and Warnings

ARNICA by is a Homeopathic medication manufactured, distributed, or labeled by CVS Health, Sheffield Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Fact

Active Ingredient

Arnica montana 1X HPUS-7%

Purpose

Trauma, muscle pain and stiffness, swelling from injuries, discoloration from bruising

REFERENCES

The letters HPUS indicate that this ingredient is offically included in the Homoepathic Pharmacopoeia of the United States.

Uses

• temporarily relieves muscle pain and stiffness due to minor injuries
• overexcertion and falls
• reduced pain, swelling and discoloration from bruises

Warnings

For external use only.Avoid contact with eyes, mucous membranes, damaged skin or wounds. Do not use if you are allergic to Arnica montana or to any of this product's inactive ingredients.

ASK DOCTOR

Stop use and ask a Doctor if conditions persists for more than 3 days or worsens.

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children. If swallowed, get medical help or contact Poison Control Center right away.Not for use of children 12 years  of age

Directions

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

Other information

• do not use if the tube seal is broken
• store at 68° to 77° F ( 20° to 25°C)

Inactive ingredients

Alcohol, Caprylyl Glycol, Carbomer, Dimethicone ( Dimethicone Copolyol), PEG-8, Phenoxyethanol, Purified Water, Sodium Hydroxide

Questions or Comment? 1-800-222-1087

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CVS Health            Compare to the active ingredient in Arnicare Gel

                              NDC: 69842-090-22

Arnica Gel

RELIEF FOR PAIN< STIFNESS & SWELLING

Homoepathic

• Quickly absorbed
• Unscented
• Non greasy
• Paraben Free            NET WT 2.6 oz (73g)

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INGREDIENTS AND APPEARANCE

ARNICA 
cvs arnica montana gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-090
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
ALCOHOL (UNII: 3K9958V90M)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CARBOMER 940 (UNII: 4Q93RCW27E)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYETHYLENE GLYCOL 800 (UNII: UH6KR4953D)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-090-22	1 in 1 CARTON	03/01/2017
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		03/01/2017

Labeler - CVS Health (062312574)

Registrant - Sheffield Pharmaceuticals LLC (151177797)

Establishment
Name	Address	ID/FEI	Business Operations
Sheffield Pharmaceuticals LLC		151177797	manufacture(69842-090)