ARNIFLORA- arnica montana gel

Arniflora by

Drug Labeling and Warnings

Arniflora by is a Homeopathic medication manufactured, distributed, or labeled by Schwabe North America, Inc, Schwabe Mexico, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient:

ARNICA MONTANA  1X 

Inactive Ingredients:

CARBOMER HOMOPOLYMER TYPE C

ETHYL ALCOHOL

PURIFIED WATER

SODIUM HYDROXIDE 

WITCH HAZEL DISTILLATE

DOSAGE & ADMINISTRATION

Dosage and Administration:

Boericke and Tafel Brand:

Directions:

Apply thin layer to affected area

Massage gently or use compress.

For best results, use promptly after injury or trauma occurs

Adults and Children 2 years of age and older:  apply to affected area up to 4 times daily

Children under 2: Consult a doctor.

Patch test recommened on sensitive skin

INDICATIONS & USAGE

Indications and Usage:

Temporarily relieves muscle pain, stiffness, and swelling associated with overexertion, sprains, falls, blows, and minor sports injuries.

Reduces pain, swelling, and discoloration from bruises

Purpose:

Temporarily relieves muscle pain, stiffness, and swelling associated with overexertion, sprains, falls, blows, and minor sports injuries.

Reduces pain, swelling, and discoloration from bruises

WARNINGS

Warnings: 

For external use only.

Avoid contact with eyes or broken skin.

Do not use if hypersensitive to any ingredients in this product.

Breast-feeding women should not apply to breast area.

Keep out of Reach of Children:

Keep out of reach of children.

Stop use and ask a doctor if

Skin irritation, rash or other allergic reaction develops, condition worsens or does not improve within 7 days or if symptoms clear up and occur againin within a few days.

This could be signs for a serious condition.

OTC - Pregnancy or Breast Feeding
If pregnant or breast-feeding, ask a healthcare professional before use.

Overdose

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

Package Label.Principal Display Panel: Boericke and Tafel Arniflora gel21825090  28 gm 21825097  78 gm  

INGREDIENTS AND APPEARANCE

ARNIFLORA  
arnica montana gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53499-5090
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 28 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
WATER (UNII: 059QF0KO0R)
WITCH HAZEL (UNII: 101I4J0U34)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53499-5090-4	1 in 1 CARTON	01/01/2011
1		28 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 53499-5090-8	1 in 1 CARTON	01/01/2011
2		78 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		01/01/2011

Labeler - Schwabe North America, Inc (831153908)

Establishment
Name	Address	ID/FEI	Business Operations
Schwabe Mexico, S.A. de C.V.		812805901	manufacture(53499-5090)