ARNICARE BRUISE- arnica montana cream

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**

Arnica montana 1X HPUS 7%

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

PURPOSE

Purpose*

Reduces minor pain, swelling, & discoloration from bruises

INDICATIONS & USAGE

Uses*

reduces symptoms of bruising such as:

• minor pain
• swelling
• discoloration

WARNINGS

For external use only.

DO NOT USE

Do not use if you are allergic to Arnica montana or to any of this product's inactive ingredients.

WHEN USING

When using this product

• avoid contact with eyes, mucous membranes, wounds, damaged or irritated skin
• use only as directed
• do not tightly wrap or bandage the treated area
• do not apply heat or ice to the treated area immediately before or after use

ASK DOCTOR

Stop use and ask a doctor if

• condition persists for more than 3 days or worsens
• symptoms clear up and occur again within a few days

PREGNANCY OR BREAST FEEDING

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

• Adults and children 1 year of age and older: Apply a thin layer of Arnicare Bruise Cream to affected area and massage gently as soon as possible after minor bruise up to 3 times a day. If heat or ice is applied, wait 5 minutes before applying Arnicare Bruise Cream.
• Children under 1 year of age: Not recommended.

SPL UNCLASSIFIED SECTION

Other information

• do not use if glued carton end flaps are open or if the tube seal is broken
• dispose of 1 year after opening

1.4 oz (40 g)

2.5 oz (70 g)

4.2 oz (120 g)

Bruise Relief*

Pain Swelling Discoloration*

ɨ Homeopathic mother tincture made from Arnica montana fresh whole plant.

*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

arachidyl alcohol, arachidyl glucoside, behenyl alcohol, Butyrospermum parkii (Shea) butter, coconut oil, glycerin, lactobacillus ferment, purified water, xanthan gum

QUESTIONS

Questions or comments?

Arnicare.com | BoironUSA.com

Info@Boiron.com

1-800-BOIRON-1 (1-800-264-7661)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ARNICARE BRUISE 
arnica montana cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0220-9085
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 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
DOCOSANOL (UNII: 9G1OE216XY)
LIMOSILACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)
COCONUT OIL (UNII: Q9L0O73W7L)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0220-9085-60	1 in 1 PACKAGE	01/21/2021
1		1 [hp_X] in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 0220-9085-63	1 in 1 CARTON	01/03/2024
2		1 [hp_X] in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 0220-9085-82	1 in 1 CARTON	01/03/2024
3		1 [hp_X] 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		01/21/2020

Labeler - Boiron (282560473)

Registrant - Boiron Inc. (014892269)

Establishment
Name	Address	ID/FEI	Business Operations
Boiron		282560473	manufacture(0220-9085)