ARNIFLORA GEL- arnica montana gel

Arniflora Gel by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient:

ARNICA MONTANA 1X

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

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:

Keep out of reach of children.

ASK DOCTOR

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.

PREGNANCY OR BREAST FEEDING

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

OVERDOSAGE

Overdose

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

INACTIVE INGREDIENT

Inactive Ingredients:

CARBOMER HOMOPOLYMER 

ETHYL ALCOHOL

PURIFIED WATER

SODIUM HYDROXIDE

WITCH HAZEL DISTILLATE

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ARNIFLORA GEL 
arnica montana gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68466-0004
Route of Administration	TOPICAL, 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: 68466-0004-4	1 in 1 CARTON	01/01/2011
1		28 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 68466-0004-8	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 Mexico S.A. de C.V. (812805901)

Registrant - Schwabe Mexico S.A. de C.V. (812805901)

Establishment
Name	Address	ID/FEI	Business Operations
Schwabe Mexico S.A. de C.V.		812805901	manufacture(68466-0004)