Arnicare Value Pack Kit
FDA Label NDC 0220-9042

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Laboratoires Boiron for the product Arnicare Value Pack (NDC 0220-9042). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, indications & usage, inactive ingredient, how supplied, otc - purpose, storage and handling, otc - questions, otc - ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Arnicare Gel:

Arnica Montana 1X

Arnica 30 C pellets:
Arnica Montana 30C

Indications & Usage

Arnicare Gel and Arnica 30 C pellets
Temporary relieves muscle pain and stiffness due to minor injuries, overexertion and falls.
Reduces pain, swelling and discoloration from bruises.

How Supplied

Gel:
1 tube 2.6 OZ (75g)

Pellets:
1 tube approx. 80 pellets each, 3.8g (0.133 oz.)


Otc - Purpose

Gel:
Arnica Montana 1X HPUS-7% ..... Trauma, muscle, pain and stiffness, swelling from injuries, discoloration from bruising.

Pellets:
Arnica montana 30C HPUS .......... Trauma, bruises and muscle soreness.


Storage And Handling

Store at 68-77 o  F (20-25 o C)

Otc - Questions

Questions, Comments
www.arnicare.com
[email protected]
1-800-BOIRON-1 (1-800-264-7661)
Boiron Information Center
6 campus Bouelvard
Newtown Square, PA
19073-3267

Otc - Ask Doctor




Otc - Stop Use


Gel:
Stop use and ask a doctor if condition persists for more than 3 days or worsens.

Pellets:
Stop use and ask a doctor if condition persists for more than 3 days or worsens.

Otc - Keep Out Of Reach Of Children


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

Pellets:
Keep out of reach of children

Otc - When Using


Drug Interactions

Unscented - Quickly absorbed -Paraben-free - non-greasy - Works naturally with your body.

Warnings

Arnicare gel:

For external use only.

Avoid contact with eyes and with open wounds.


Dosage & Administration

Gel:
Apply a thin layer of Arnicare Gel to affected area as soon as possible after minor injury. Repeat 3 times a day or as needed.

Pellets:
Adults and children 2 years of age and older: Dissolve 5 pellets in the mouth 3 times a day until relieved or as directed by a doctor.


Otc - Pregnancy Or Breast Feeding

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

* Please review the disclaimer below.