arnicare foot care

arnicare foot care
SPL v9
SPL
SPL Set ID 6b3c511c-7b11-203f-e053-2991aa0a6e01
Route
topical
Published
Effective Date 2024-08-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
arnica montana (1 [hp_X])
Inactive Ingredients
butyrospermum parkii (shea) butter unsaponifiables limosilactobacillus fermentum water xanthan gum coconut oil glycerin arachidyl alcohol docosanol arachidyl glucoside

Identifiers & Packaging

Marketing Status
unapproved homeopathic active Since 2018-06-01 Until 2026-11-30

Description

Active Ingredient ** Arnica montana 1X HPUS 7% 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

Warnings

For external use only.

Active Ingredient

Active Ingredient **

Arnica montana 1X HPUS 7%

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

Indications and Usage

Uses*

temporarily relieves symptoms of overexertion and minor muscle and joint injuries such as:

  • sore feet
  • aches
  • pains
  • reduces symptoms of sprains and strains such as:
  • minor pain
  • swelling
  • discoloration from bruises
Dosage and Administration

Directions

  • Adults and children 1 year of age and older: Apply a thin layer of Arnicare FootCare 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 FootCare Cream.
  • Children under 1 year of age: Not recommended.
Description

Active Ingredient ** Arnica montana 1X HPUS 7% 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.

dispose of 1 year after opening

4.2 oz (120g)

Sore & Aching Feet Swelling from Sprains Joint Pain*

Foot Pain Relief*

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.

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if

  • condition persists for more than 3 days or worsen
  • 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 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

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

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 19073-3267

Section 55105-1

Purpose*

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


Structured Label Content

Warnings and Precautions (34071-1)

Warnings

For external use only.

Active Ingredient (55106-9)

Active Ingredient **

Arnica montana 1X HPUS 7%

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

Indications and Usage (34067-9)

Uses*

temporarily relieves symptoms of overexertion and minor muscle and joint injuries such as:

  • sore feet
  • aches
  • pains
  • reduces symptoms of sprains and strains such as:
  • minor pain
  • swelling
  • discoloration from bruises
Dosage and Administration (34068-7)

Directions

  • Adults and children 1 year of age and older: Apply a thin layer of Arnicare FootCare 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 FootCare Cream.
  • Children under 1 year of age: Not recommended.
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

4.2 oz (120g)

Sore & Aching Feet Swelling from Sprains Joint Pain*

Foot Pain Relief*

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.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact 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 worsen
  • 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 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)

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

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 19073-3267

Section 55105-1 (55105-1)

Purpose*

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


Advanced Ingredient Data


Raw Label Data

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