FDA Label for Kids Relief Calendula
View Indications, Usage & Precautions
Kids Relief Calendula 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
Calendula officinalis (Marigold) 1X
Echinacea angustifolia (Coneflower) 1X
Hypericum perforatum (St John's wort) 3X
Phytolacca decandra (American nightshade) 3X
Cantharis (Spanish fly) 3X
Sulphur (Sulfur) 3X
Purpose
Cuts, burns
Itching skin
Scrapes, scars
Itchy dry skin
Burning pain
Chapped rough skin
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 components in this product are officially monographed in the Homoeopathic Pharmacopoeia of the United States.
Uses
This homeopathic medicine is made from a combination of ingredients traditionally used to help:
- promote healing of minor cuts, scrapes, scars and burns
- soften itchy dry, rough or chapped skin.
Warnings
Route, Method And Frequency Of Administration
For external use only.
Otc - Do Not Use
Do not use if film wrapper is broken or missing.
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
- Clean affected area and apply a thin layer 3 times a day or as needed. May be covered with a sterile bandage.
- Children under 2 yrs: ask a doctor.
Other Information
Store at room temperature (68 - 77°F).
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.
Label
* Please review the disclaimer below.