FDA Label for Alumier Md Post Procedure Kit With Hydrocortisone

Active Ingredients

Clear Shield:

Titanium Dioxide 7%

Zinc Oxide 6.18%

Intensive Recovery:

Hydrocortisone 1.0%

Purpose

Clear Shield:

Sunscreen

Intensive Recovery:

Anti-itch cream

Uses

Clear Shield:

• helps prevent sunburn

Intensive Recovery:

• adults and children 2 years of age and older: For the temporary relief of minor skin irritations, rashes, itching and redness due to eczema, insect bites, poison ivy, poison oak, poison sumac, contact dermatitis (e.g. caused by soaps, detergents, cosmetics and/or jewelry), seborrheic dermatitis, psoriasis.

Warnings

For external use only

Do Not Use

Clear Shield:

• on broken skin

Intensive Recovery:

• for the treatment of diaper rash, except on the advice of a physician

When Using This Product

Clear Shield:

• avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Intensive Recovery:

• avoid contact with eyes, do not use in or around the eyes

Stop Use And Ask A Doctor

Clear Shield:

• if rash occurs

Intensive Recovery:

• if condition worsens or if symptoms persist for more than 7 days or clears up and occurs again within a few days. Do not begin use of any other hydrocortisone product unless directed by a physician.

Keep Out Of Reach Of Children

If swallowed, call a Poison Control Centre or get medical help right away.

Directions

Clear Shield:

• apply liberally/generously (and evenly) 15 minutes before sun exposure
• reapply at least every 2 hours
• 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

Intensive Recovery:

• adults and children 2 years of age and older, apply sparingly to affected area not more than three to four times daily
• do not use on children under 2 years of age, consult a physician

Other Information

Clear Shield:

• Store in a cool, dry place at room temperature.
• Do not use if security seal on box is broken or missing.
• You may report a serious adverse reaction event from using this product to: Alumier Labs Inc., 945 Concord Street, Framingham, MA 01701

Intensive Recovery:

• Do not use if security seal on box is broken or missing.
• You may report a serious adverse reaction event from using this product to: Alumier Labs Inc., 945 Concord Street, Framingham, MA 01701

Non-Medicinal Ingredients

Clear Shield:

Water/Aqua/Eau, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Niacinamide, Propanediol, Dimethicone, Butyloctyl Salicylate, Glycerin, Caprylyl Methicone, Cetearyl Alcohol, Aluminium Stearate, Glyceryl Stearate, PEG-100 Stearate, Vitis Vinifera Seed Extract, Sodium Hyaluronate, Resveratrol, Lecithin, Magnesium Ascorbyl Phosphate, Tocopheryl Acetate, Glutathione, Acacia Senegal Gum, Cellulose Gum, Microcrystalline Cellulose, Polysilicone-11, Triethoxycaprylylsilane, Ceteareth-20, Polyhydroxystearic Acid, Xanthan Gum, Disodium EDTA, Alumina, Tocopherol, Alteromonas Ferment Extract, Butylene Glycol, Physalis Angulata Extract, Polygonum Aviculare Extract, Xylitol, Caprylic Acid, Caprylyl Glycol, Polymethyl Methacrylate, Tricaprylin, Sodium Benzoate, Potassium Sorbate, Pentylene Glycol, Ethylhexylglycerin.

Intensive Recovery:

Water/Aqua/Eau, Butyrospermum Parkii (Shea Butter), Simmondsia Chinensis (Jojoba) Seed Oil, Glycerin, Caprylic/Capric Triglyceride, Dimethicone, Propanediol, Theobroama Cacao (Cocoa) Seed Butter, Aloe Barbadensis Leaf Juice, Niacinamide, Resveratrol, Poria Cocos Sclerotium Extract, Boswellia Serrata Gum Extract, Honey Extract (Extait De. Miel), Tetrapeptide-14, Copper Tripeptide-1, Aspalathus Linearis Extract, Ceramide NP, Ceramide NG, Squalane, Hydrogenated Lecithin, Sodium Acrylates Copolymer, Lecithin, Behenyl Alchol, Xanthan Gum, Caprylic Acid, Sodium Methyl Stearoyl Taurate, Tricaprylin, Polymethyl Methacrylate, Sodium Hydroxide, Disodium EDTA, Caprylyl Glycol, Xylitol, Ethylhexylglycerin.

Product Packaging

2 - sensicalm1