ARNICARE BRUISE- arnica montana tablet

Arnicare Bruise by

Drug Labeling and Warnings

Arnicare Bruise by is a Homeopathic medication manufactured, distributed, or labeled by Boiron, Boiron Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient** (in each tablet)

Arnica montana 9C HPUS (2.5 mg)

The letters "HPUS" indicate that the component in this product is officially monographed in the Homeopathic Pharmacopoeia of the United States.

PURPOSE

Purpose*

Arnica montana 9C HPUS (2.5 mg) ... Reduces minor pain, swelling & discoloration from bruises

INDICATIONS & USAGE

Uses*

reduces symptoms of bruising such as:

• minor pain
• swelling
• discoloration

WARNINGS

ASK DOCTOR

Ask a doctor before use if bruising limits the range of motion of your eyes, limbs, head, pain is severe, or bruising is frequent.

STOP USE

Stop use and ask a doctor if

• adult's symptoms get worse or last more than 7 days
• child's symptoms get worse or last more than 5 days
• new symptoms occur, or if redness or swelling is present. These could be signs of a serious condition.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health profession before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

Adults and children 6 years of age and older - As soon as bruising occurs, dissolve 2 tablets under the tongue and repeat 3 times a day. Decrease frequency with improvement.

Children 2 to 6 years of age - Dissolve 2 tablets in 1 tablespoon of water for easier intake. Follow directions above.

Children under 2 years of age - Ask a doctor.

SPL UNCLASSIFIED SECTION

• do not use if glued carton end flaps are open or if the blister seal is broken
• store below 86° F (30° C)

60 meltaway tablets

Bruise relief*

Discoloration, Pain, Swelling*

No Known Drug Interactions

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

**C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.

INACTIVE INGREDIENT

croscarmellose sodium, lactose, magnesium stearate

QUESTIONS

Arnicare.com

BoironUSA.com

Info@Boiron.com

1-800-BOIRON-1

(1-800-264-7661)

Made in France

Distributed by Boiron Inc.

Newtown Square, PA 19073

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ARNICARE BRUISE 
arnica montana tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0220-9083
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	9 [hp_C]

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)

Product Characteristics
Color	white	Score	no score
Shape	ROUND (Boiron)	Size	9mm
Flavor		Imprint Code	;
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0220-9083-04	60 in 1 BLISTER PACK; Type 0: Not a Combination Product	01/18/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/18/2022

Labeler - Boiron (282560473)

Registrant - Boiron Inc. (014892269)

Establishment
Name	Address	ID/FEI	Business Operations
Boiron		282560473	manufacture(0220-9083)