Arnicare Cream

Arnicare Cream
SPL v20
SPL
SPL Set ID 542b41dd-f285-4e48-a67b-8e69523b143a
Route
TOPICAL
Published
Effective Date 2025-12-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arnica Montana (1 [hp_X])
Inactive Ingredients
Arachidyl Glucoside Glycerin Docosanol Water Coconut Oil Arachidyl Alcohol Xanthan Gum Limosilactobacillus Fermentum Butyrospermum Parkii (shea) Butter Unsaponifiables

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2007-03-01

Description

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.


Medication Information

Warnings and Precautions

For external use only.

Indications and Usage
  • temporarily relieves minor muscle pain and stiffness due to:
  • minor injuries
  • overexertion
  • falls
  • reduces symptoms of bruising such as:
  • pain
  • swelling
  • discoloration
Dosage and Administration
  • Adults and children 1 year of age and older: Apply a thin layer of Arnicare cream to affected area and massage gently as soon as possible after minor injury up to 3 times a day. If heat or ice is applied, wait 5 minutes before applying Arnicare Cream.
  • Children under 1 year of age: Not recommended.
Description

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.

Section 42229-5

do not use if glued carton end flaps are open

dispose of 1 year after opening

0.5 oz (14 g)

1.4 oz (40 g)

2.5 oz (70 g)

4.2 oz (120 g)

Pain Relief*

Muscle Pain & Stiffness Swelling from Injuries Bruises*

*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.

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

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

Section 50565-1

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

Section 50566-9

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
Section 50567-7

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 threated area immediately before or after use
Section 50570-1

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

Section 51727-6

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

alcohol, caprylyl glycol, carbomer, cetyl palmitate, glycerin, lauroyl, macrogolglycerides, pegoxol-7 stearate, purified water, sodium hydroxide, sorbic acid, 1,2-hexanediol

Section 51945-4

Section 53413-1

Arnicare.com

BoironUSA.com

[email protected]

1-800-BOIRON-1

(1-800-264-7661)

Distributed by Boiron Inc.

Newtown Square, PA 19073

Section 55105-1

Purpose*

Relieves minor muscle pain & stiffness, swelling from injuries, discoloration from bruises

Section 55106-9

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.


Structured Label Content

Indications and Usage (34067-9)
  • temporarily relieves minor muscle pain and stiffness due to:
  • minor injuries
  • overexertion
  • falls
  • reduces symptoms of bruising such as:
  • pain
  • swelling
  • discoloration
Dosage and Administration (34068-7)
  • Adults and children 1 year of age and older: Apply a thin layer of Arnicare cream to affected area and massage gently as soon as possible after minor injury up to 3 times a day. If heat or ice is applied, wait 5 minutes before applying Arnicare Cream.
  • Children under 1 year of age: Not recommended.
Warnings and Precautions (34071-1)

For external use only.

Section 42229-5 (42229-5)

do not use if glued carton end flaps are open

dispose of 1 year after opening

0.5 oz (14 g)

1.4 oz (40 g)

2.5 oz (70 g)

4.2 oz (120 g)

Pain Relief*

Muscle Pain & Stiffness Swelling from Injuries Bruises*

*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.

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

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

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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
Section 50567-7 (50567-7)

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 threated area immediately before or after use
Section 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

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

alcohol, caprylyl glycol, carbomer, cetyl palmitate, glycerin, lauroyl, macrogolglycerides, pegoxol-7 stearate, purified water, sodium hydroxide, sorbic acid, 1,2-hexanediol

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Arnicare.com

BoironUSA.com

[email protected]

1-800-BOIRON-1

(1-800-264-7661)

Distributed by Boiron Inc.

Newtown Square, PA 19073

Section 55105-1 (55105-1)

Purpose*

Relieves minor muscle pain & stiffness, swelling from injuries, discoloration from bruises

Section 55106-9 (55106-9)

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.


Advanced Ingredient Data


Raw Label Data

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