Arnicare Gel

Arnicare Gel
SPL v25
SPL
SPL Set ID ce519152-e6fb-42e3-8fd4-f819476ebd86
Route
TOPICAL
Published
Effective Date 2025-07-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arnica Montana (1 [hp_X])
Inactive Ingredients
Alcohol Water Sodium Hydroxide Carbomer Homopolymer Type C

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2007-01-09

Description

Active ingredient** Arnica montana 1X HPUS 7% The letters "HPUS" indicate that the component in this product is officially monographed in the Homeopathic Pharmacopoeia of the United States.


Medication Information

Warnings and Precautions

Warnings

For external use only.

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

When using this product

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 treated area immediately before or after use.

Indications and Usage

Uses*

temporarily relieves muscle pain and stiffness due to:

  • minor injuries
  • overexertion
  • falls

reduces symptoms of bruising such as:

  • pain
  • swelling
  • discoloration

Dosage and Administration

Directions

Apply a thin layer of Arnicare Gel to the affected area as soon as possible after minor injury. Repeat 3 times a day or as needed. If heat or ice is applied, wait 5 minutes before applying Arnicare Gel.A

Arnicare Gel Roll-On - Twist roller to the "ON" position and gently squeeze tube to apply a thin layer of product to affected area. Twist roller to the "OFF" position and continue massaging as needed. Repeat 3 times a day. If heat or ice is applied, wait 5 minutes before applying Arnicare Roll-on Gel.

Description

Active ingredient** Arnica montana 1X HPUS 7% The letters "HPUS" indicate that the component in this product is officially monographed in the Homeopathic Pharmacopoeia of the United States.

Section 42229-5

Other information

do not use if glued carton end flaps are open or if the tube seal is broken

do not use if pouch is torn or open

Arnicare Gel 0.18 oz (5g)- dispose 1 day after opening

Arnicare Gel Roll-On (2023)- dispose of 1 year after opening

0.18 oz (5g)

0.5 oz (14g)

1.5 oz (45g)

2.6 oz (75g)

4.2 oz (120g)

3 oz (90g)

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.

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 51727-6

Alcohol, carbomer, purified water, sodium hydroxide

Section 51945-4

Section 53413-1

Questions, Comments?

Distributed by Boiron, Inc., Newtown Square, PA 19073

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

BoironUSA.com

Arnicare.com

[email protected]

Made in France

Section 55105-1

Purpose*

Arnica montana 1X HPUS 7% Relieves 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 is officially monographed in the Homeopathic Pharmacopoeia of the United States.


Structured Label Content

Indications and Usage (34067-9)

Uses*

temporarily relieves muscle pain and stiffness due to:

  • minor injuries
  • overexertion
  • falls

reduces symptoms of bruising such as:

  • pain
  • swelling
  • discoloration

Dosage and Administration (34068-7)

Directions

Apply a thin layer of Arnicare Gel to the affected area as soon as possible after minor injury. Repeat 3 times a day or as needed. If heat or ice is applied, wait 5 minutes before applying Arnicare Gel.A

Arnicare Gel Roll-On - Twist roller to the "ON" position and gently squeeze tube to apply a thin layer of product to affected area. Twist roller to the "OFF" position and continue massaging as needed. Repeat 3 times a day. If heat or ice is applied, wait 5 minutes before applying Arnicare Roll-on Gel.

Warnings and Precautions (34071-1)

Warnings

For external use only.

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

When using this product

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 treated area immediately before or after use.

Section 42229-5 (42229-5)

Other information

do not use if glued carton end flaps are open or if the tube seal is broken

do not use if pouch is torn or open

Arnicare Gel 0.18 oz (5g)- dispose 1 day after opening

Arnicare Gel Roll-On (2023)- dispose of 1 year after opening

0.18 oz (5g)

0.5 oz (14g)

1.5 oz (45g)

2.6 oz (75g)

4.2 oz (120g)

3 oz (90g)

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.

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 51727-6 (51727-6)

Alcohol, carbomer, purified water, sodium hydroxide

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions, Comments?

Distributed by Boiron, Inc., Newtown Square, PA 19073

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

BoironUSA.com

Arnicare.com

[email protected]

Made in France

Section 55105-1 (55105-1)

Purpose*

Arnica montana 1X HPUS 7% Relieves 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 is officially monographed in the Homeopathic Pharmacopoeia of the United States.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)