FDA Label for Kids Relief Arnica
View Indications, Usage & Precautions
Kids Relief Arnica Product Label
The following document was submitted to the FDA by the labeler of this product Homeolab Usa Inc. 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.
Active Ingredients Hpus
Arnica montana (Leopard's bane) 1X
Hypericum perforatum (St John's Wort) 1X
Purpose
Pain, bruises, sprains, muscle aches
Bruises, strains
These claims have not been reviewed by the Food and Drug Administration. They are based on traditional homeopathic practice.
References
The letters "HPUS" indicate that the ingredients in this product are officially monographed in the Homoeopathic Pharmacopoeia of the United States.
Uses
This homeopathic medecine is made from a combination of ingredients traditionally used to help relieve symptoms associated with:
- minor bruises
- strains
- sprains
- muscle aches
Warnings
Route, Method And Frequency Of Administration
For external use only.
Otc - Do Not Use
Do not use on broken skin.
Otc - When Using
When using this product, avoid contact with eyes; if contact occurs, rinse abundantly with water to remove.
Otc - Stop Use
Stop use and ask a doctor
- if symptoms persist for more than 3 days or worsen
- if hypersensitivity and/or allergy occurs.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If ingested, get medical help or contact a Poison Control Center immediately.
Directions
- Apply a thin layer to the affected area, rub in gently. Repeat 3 times a day or as needed.
- Children under 2 yrs: ask a doctor.
Other Information
- Store at room temperature (68 - 77°F)
- Do not use if tube seal is broken.
Inactive Ingredients
Carbomer, ceteareth-12, cetearyl alcohol, cetyl alcohol, cetyl palmitate, DMDM hydantoin, glycerin, glyceryl cocoate, glyceryl stearate, iodopropynyl butylcarbamate, isopropyl myristate, isopropyl palmitate, octyldodecanol, PEG-20 glyceryl stearate, PEG-100 stearate, purified water, sodium hydroxide, sorbitan stearate.
Carton
Tube
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