Alumier MD Post Procedure Kit with Hydrocortisone

Manufacturer
Alumier Labs
Effective date
2024-12-02
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:40:12

Label at a glance#

ProductAlumier MD Post Procedure Kit with Hydrocortisone
Active ingredientZINC OXIDE, TITANIUM DIOXIDE, HYDROCORTISONE
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 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

insideinsideboxboxboxbox

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
15bd4439-874a-4934-9954-248e5455d460Product name120260310
9962b773-9f2e-22cc-0032-535e48ac417bProduct name320250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2Product name120250325
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
4d56e8eb-d741-d4a5-de3f-2bab1af75a60Product name720220608
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
e7d5a174-836b-a0af-b014-cb0826c69ddcProduct name220181004
fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1Product name220150218
02657a3f-1489-66ea-f740-5ab9524e57d7Product name120140508
26f3d783-2cc1-4327-e77d-71804cf675a2Product name120140508
36fdc54c-bbeb-981e-8a53-4d768e283892Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
61e59a42-186b-9f4b-aec3-fb49a6debc31Product name120140508
705740e1-dee5-2610-c5a3-4c59cd9d62afProduct name120140508
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0Product name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fdProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69473-006ALUMIER MD POST PROCEDURE KIT WITH HYDROCORTISONE (TITANIUM DIOXIDE, ZINC OXIDE, HYDROCORTISONE) KIT [ALUMIER LABS]3Current NDC, Legacy NDC20241204_dacebb7f-cf6b-6508-e053-2a95a90a2d19.zip
69473-017ALUMIER MD POST PROCEDURE KIT WITH HYDROCORTISONE (TITANIUM DIOXIDE, ZINC OXIDE, HYDROCORTISONE) KIT [ALUMIER LABS]3Current NDC, Legacy NDC20241204_dacebb7f-cf6b-6508-e053-2a95a90a2d19.zip
69473-018ALUMIER MD POST PROCEDURE KIT WITH HYDROCORTISONE (TITANIUM DIOXIDE, ZINC OXIDE, HYDROCORTISONE) KIT [ALUMIER LABS]3Legacy NDC20241204_dacebb7f-cf6b-6508-e053-2a95a90a2d19.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 3 · 89 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69473-01869473-018-01
69473-00669473-006-04
69473-01769473-017-02

Ingredients#

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

DailyMed ingredient rows page 1 of 3 · 103 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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alumier MD Intensive RecoveryHYDROCORTISONEAlumier Labsd9b79ea1-6558-543c-e053-2995a90ae53e2025-08-06WarningsExact identifier
ndc (product): 69473-017
Alumier MD Sheer HydrationTITANIUM DIOXIDE, ZINC OXIDEAlumier Labs88dedeb8-963f-5849-e053-2995a90aab722024-12-12WarningsExact identifier
ndc (product): 69473-006
284a7b0b-536b-f140-e063-6394a90a1671dacebb7f-cf6b-6508-e053-2a95a90a2d192024-12-02WarningsExact identifier
spl id: 284a7b0b-536b-f140-e063-6394a90a1671
spl set id: dacebb7f-cf6b-6508-e053-2a95a90a2d19

Reported adverse events (FAERS/openFDA)#

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