FDA Label for Arnicare Value Pack
View Indications, Usage & Precautions
- OTC - ACTIVE INGREDIENT
- INDICATIONS & USAGE
- INACTIVE INGREDIENT
- HOW SUPPLIED
- OTC - PURPOSE
- STORAGE AND HANDLING
- OTC - QUESTIONS
- OTC - ASK DOCTOR
- OTC - STOP USE
- OTC - KEEP OUT OF REACH OF CHILDREN
- OTC - WHEN USING
- DRUG INTERACTIONS
- WARNINGS
- DOSAGE & ADMINISTRATION
- OTC - PREGNANCY OR BREAST FEEDING
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Arnicare Value Pack Product Label
The following document was submitted to the FDA by the labeler of this product Laboratoires Boiron. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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.
Inactive Ingredient
Gel: alcohol, carbomer, purified water, sodium hydroxide.
Pellets: Lactose, Sucrose.
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.