Alumier MD Post Procedure Kit with Hydrocortisone

Manufacturer
Alumier Labs
Effective date
2020-11-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:04:21

Label at a glance#

ProductAlumier MD Post Procedure Kit with Hydrocortisone
Active ingredientZINC OXIDE, TITANIUM DIOXIDE, HYDROCORTISONE ACETATE
Label structure16 sections

Indications and uses

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.

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone (Hydrocortisone acetate) 1.0%

Purpose

OTC - PURPOSE SECTION

Anti-itch cream

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

  • For external use only

OTC - DO NOT USE SECTION

  • do not use for the treatment of diaper rash, except on the advise of a physician

OTC - WHEN USING SECTION

When using this product

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

OTC - STOP USE SECTION

Stop use and ask a doctor 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, call a Poison Control Centre or get medical help right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

OTHER SAFETY 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., 550 Cochituate Road, Suite 25, Framingham, MA 01701

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water/Aqua/Eau, Butyrospermum Parkii (Shea Butter), Simmondsia Chinensis (Jojoba) Seed Oil, Glycerin, Dimethicone, Caprylic/Capric Triglyceride, Behenyl Alcohol, Theobroma Cacao (Cocoa) Seed Butter, Sodium Acrylates Copolymer, Niacinamide, Aloe Barbadensis Leaf Juice, Hinokitiol, Resveratrol, Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract, Anthemis Nobilis Flower Extract, Sea Whip Extract, Boswellia Serrata Extract, Honey Extract (Extrait de Miel), Tetrapeptide-14, Copper Tripeptide-1, Camellia Sinensis Leaf Extract, Aspalathus Linearis (Rooibos) Extract, Eucalyptus Globulus Leaf Extract, Mentha Viridis (Spearmint) Extract, Pogostemon Cablin Leaf Extract, Pyrus Malus (Apple) Fruit Extract, Rose Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Hydrogenated Lecithin, Squalane, Lecithin, Xanthan Gum, Caprylic Acid, Pentylene Glycol, Isosqualane, Sodium Methyl Stearoyl Taurate, Tricaprylin, Polymethyl Methacrylate, Sodium Hydroxide, Disodium EDTA, Caprylyl Glycol, Xylitol, Ethylhexylglycerin.

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 7%

Zinc Oxide 6.28%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Use

INDICATIONS & USAGE SECTION

  • helps prevent sunburn

Warnings

WARNINGS SECTION

  • For external use only

OTC - WHEN USING SECTION

When using this product

  • do not use on damaged or broken skin
  • keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

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 SECTION

Keep out of reach of children. If swallowed, call a Poison Control Centre or get medical help right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

Other Information

OTHER SAFETY 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

INACTIVE INGREDIENT SECTION

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, C20-4O Pareth-10, Hydroxyethyl Behenamidopropyl Dimonium Chloride, Polyquatemium-67, Disodium EDTA, Ethylhexylglycerin, Phenoxyethanol.

Company Information

SPL UNCLASSIFIED SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

kit insertkit insertkit boxkit boxkit box insidekit box inside

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69473-01369473-013-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 3 · 99 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
dae79ed6-701e-a1c3-e053-2a95a90a6e85b4900ff3-630b-6893-e053-2995a90ac3572022-03-23WarningsExact identifier
spl set id: b4900ff3-630b-6893-e053-2995a90ac357

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.