Arnicare Ointment

Arnicare Ointment
SPL v7
SPL
SPL Set ID 9d03bd9c-ab1e-4414-afd2-8f9c80000164
Route
CUTANEOUS
Published
Effective Date 2024-12-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arnica Montana (1 [hp_X])
Inactive Ingredients
Alcohol Water Petrolatum

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2007-06-02

Description

Active ingredients** Arnica montana 1X HPUS 4% 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

For external use only.

Indications and Usage

Uses*

  • temporarily relieves minor muscle pain, minor joint 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 Ointment to affected area 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 Ointment.
  • Children under 1 year of age: Not recommended.
Description

Active ingredients** Arnica montana 1X HPUS 4% The letters "HPUS" indicate that the component in this product is 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

dispose of 1 year after opening

1 oz (30g)

Pain Relief*

Muscle Pain & Stiffness Swelling from Injuries Bruises*

ɨ Homeopathic 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.

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

Section 50565-1

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

Section 50566-9

Stop use and ask doctor if

  • condition persists for more than 3 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
  • 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

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

Section 51727-6

alcohol, purified water, white petrolatum USP

Section 51945-4

Section 53413-1

Questions, Comments?

Arnicare.com

Boironusa.com

[email protected]

1-800-BOIRON-1

(1-800-264-7661)



Distributed by Boiron Inc.

Newtown Square, PA 19073-3267

Section 53414-9



Section 55105-1

Purpose*

Arnica montana 1X HPUS 4% ... Relieves minor muscle pain & stiffness, swelling from injuries, discoloration from bruises

Section 55106-9

Active ingredients**

Arnica montana 1X HPUS 4%

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 minor muscle pain, minor joint 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 Ointment to affected area 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 Ointment.
  • 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 or if the tube seal is broken

dispose of 1 year after opening

1 oz (30g)

Pain Relief*

Muscle Pain & Stiffness Swelling from Injuries Bruises*

ɨ Homeopathic 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.

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

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask 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)
  • 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

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)

alcohol, purified water, white petrolatum USP

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions, Comments?

Arnicare.com

Boironusa.com

[email protected]

1-800-BOIRON-1

(1-800-264-7661)



Distributed by Boiron Inc.

Newtown Square, PA 19073-3267

Section 53414-9 (53414-9)



Section 55105-1 (55105-1)

Purpose*

Arnica montana 1X HPUS 4% ... Relieves minor muscle pain & stiffness, swelling from injuries, discoloration from bruises

Section 55106-9 (55106-9)

Active ingredients**

Arnica montana 1X HPUS 4%

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

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