FDA Label for Alumier Md Post Procedure Kit
View Indications, Usage & Precautions
Alumier Md Post Procedure Kit Product Label
The following document was submitted to the FDA by the labeler of this product Alumier Labs. 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
Titanium Dioxide 7%
Zinc Oxide 6.28%
Purpose
Sunscreen
Use
- helps prevent sunburn
Warnings
- For external use only
Otc - When Using
When using this product
- do not use on damaged or broken skin
- keep out of eyes. Rinse with water to remove.
Otc - Stop Use
Stop use and ask a doctor if you develop severe irritation, burning or itching of the skin, hives, swelling of eyes and mouth, blistering or difficulty breathing
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, call a Poison Control Centre or get medical help right away.
Directions
- apply liberally/generously (and evenly) 15 minutes before sun exposure
- reapply at least every 2 hours
- for use on children less than 6 months of age, consult a health care practitioner
- Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: - limit time in the sun, especially from 10 a.m. - 2 p.m. - wear long-sleeved shirts, pants, hats and sunglasses
- use a water resistant sunscreen if swimming or sweating
Other Information
- Do not use if security seal is broken or missing.
- You may report a serious adverse reaction event from using this product to: Alumier Labs Inc., Cochituate Road, Suite 25, Framingham, MA 01701
Inactive Ingredients
Water/Aqua/Eau, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Propanediol, Butyloctyl Salicylate, Cetearyl Alcohol, Aluminium Stearate, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Lecithin (Syn. Phosphatidycholine), Vitis Vinifera Seed Extract, Resveratrol, Glutathione, Tocopheryl Acetate, Magnesium Ascorbyl Phosphate, Acacia Senegal Gum, Synthetic Wax, Polyhydroxysteric Acid, Ceteareth-20, Alumina, Microcrystalline Cellulose, Triethoxycaprylylsilane, Xanthan Gum, Cellulose Gum, C20-40 Pareth-10, Hydroxyethyl Behenamidopropyl Dimonium Chloride, Polyquatemium-67, Disodium EDTA, Ethylhexylglycerin, Phenoxyethanol.
Company Information
Alumier MD
ALUMIER EUROPE LTD.
5 ST. FREDERICK STREET
VALLETTA VLT 1470, MALTA
WWW.ALUMIERMD.COM
EUROPE • UNITED STATES • CANADA • UNITED KINGDOM
MANUFACTURED IN CANADA UNDER LICENSE FROM ALUMIER EUROPE LTD.
Product Packaging
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