Arnicare Arthritis Cream

Arnicare Arthritis Cream
SPL v10
SPL
SPL Set ID da6c81e6-2c76-56de-e053-2a95a90a0397
Route
TOPICAL
Published
Effective Date 2025-05-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Harpagophytum Procumbens Root (1 [hp_X]) Harpagophytum Zeyheri Root Arnica Montana
Inactive Ingredients
Alcohol Water Sodium Acryloyldimethyltaurate-acrylamide Copolymer (1:1; 90000-150000 Mpa.s) Polysorbate 80 Acrylamide Chlorhexidine Gluconate Sorbitan Monooleate Glycerin Isohexadecane Almond Oil

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2022-03-17

Description

Active ingredients** Arnica montana 1X HPUS 7% Harpagophytum 1X HPUS 3% The letters "HPUS" indicate that the components 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

Uses*

temporarily relieves minor joint and muscle pain and stiffness due to:

arthritis

minor injuries

overexertion

falls

repetitive motions

Dosage and Administration

Directions

  • Adults and children 12 years of age and older: Apply a thin layer of Arnicare Arthritis to affected area as soon as possible at the onset of symptoms up to 4 times a day. If heat or ice is applied, wait 5 minutes before applying Arnicare Arthritis.
  • Children under 12 years of age: Ask a doctor.
Description

Active ingredients** Arnica montana 1X HPUS 7% Harpagophytum 1X HPUS 3% The letters "HPUS" indicate that the components 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 or if the tube seal is broken
  • store below 77° F (25° C)
  • do not use if pouch is torn or open
  • dispose of 1 day after opening
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

  • conditions persists for more than 7 days or worsens
  • symptoms clear up and occur again within a few days
Section 50567-7
  • avoid contact with eyes, mucous membranes, wounds, damaged or irritated skin
  • use only as directed
  • dryness or irritation may occur
  • do not tightly wrap or bandage the treated area
  • do not apply heat or ice to the treated area immediately before or after use
Section 50570-1
  • if you are allergic to Arnica montana, Harpagophytum or to any of this product's inactive ingredients
  • with other topical products for pain
Section 51727-6

acrylamide/sodium acryloyldimethyltaurate copolymer , alcohol, chlorhexidine digluconate, glycerin, isohexadecane, polysorbate 80, purified water, sorbitan oleate, sweet almond oil

Section 51945-4

Section 53413-1

Questions or comments?

Arnicare.com

BoironUSA.com

[email protected]

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

Made in France

Distributed by Boiron, Inc.

Newtown Square, PA 19073

Section 53414-9

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

Section 55105-1

Purpose*

Arnica montana 1X HPUS 7% ... Relieves minor muscle pain and stiffness, discoloration from bruises

Harpagophytum 1X HPUS 3% ... Relieves minor joint discomfort and stiffness

Section 55106-9

Active ingredients**

Arnica montana 1X HPUS 7%

Harpagophytum 1X HPUS 3%

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


Structured Label Content

Indications and Usage (34067-9)

Uses*

temporarily relieves minor joint and muscle pain and stiffness due to:

arthritis

minor injuries

overexertion

falls

repetitive motions

Dosage and Administration (34068-7)

Directions

  • Adults and children 12 years of age and older: Apply a thin layer of Arnicare Arthritis to affected area as soon as possible at the onset of symptoms up to 4 times a day. If heat or ice is applied, wait 5 minutes before applying Arnicare Arthritis.
  • Children under 12 years of age: Ask a doctor.
Warnings and Precautions (34071-1)

For external use only.

Section 42229-5 (42229-5)
  • do not use if glued carton end flaps are open or if the tube seal is broken
  • store below 77° F (25° C)
  • do not use if pouch is torn or open
  • dispose of 1 day after opening
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

  • conditions persists for more than 7 days or worsens
  • symptoms clear up and occur again within a few days
Section 50567-7 (50567-7)
  • avoid contact with eyes, mucous membranes, wounds, damaged or irritated skin
  • use only as directed
  • dryness or irritation may occur
  • do not tightly wrap or bandage the treated area
  • do not apply heat or ice to the treated area immediately before or after use
Section 50570-1 (50570-1)
  • if you are allergic to Arnica montana, Harpagophytum or to any of this product's inactive ingredients
  • with other topical products for pain
Section 51727-6 (51727-6)

acrylamide/sodium acryloyldimethyltaurate copolymer , alcohol, chlorhexidine digluconate, glycerin, isohexadecane, polysorbate 80, purified water, sorbitan oleate, sweet almond oil

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?

Arnicare.com

BoironUSA.com

[email protected]

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

Made in France

Distributed by Boiron, Inc.

Newtown Square, PA 19073

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose*

Arnica montana 1X HPUS 7% ... Relieves minor muscle pain and stiffness, discoloration from bruises

Harpagophytum 1X HPUS 3% ... Relieves minor joint discomfort and stiffness

Section 55106-9 (55106-9)

Active ingredients**

Arnica montana 1X HPUS 7%

Harpagophytum 1X HPUS 3%

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


Advanced Ingredient Data


Raw Label Data

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