Alumier MD Intensive Recovery

Manufacturer
Alumier Labs
Effective date
2019-05-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:19:38

Label at a glance#

ProductAlumier MD Intensive Recovery
Active ingredientHYDROCORTISONE ACETATE
Label structure9 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, poson 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, poson 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 ocndition 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, Caprylic/Capric Triglyceride, Butylene Glycol, Glycerin, Dimethicone, Propanediol, Theobroma Cacao (Cocoa) Seed Butter, Cetearyl Alcohol, Cyclopentasiloxane, Glyceryl Stearate, PEG-100 Stearate, Ceteareth-20, Aloe Barbadensis Leaf Juice, Niacinamide, Steareth-21, Hinokitiol, Resveratrol, Copper Tripeptide-1, Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract, Anthemis Nobilis Flower Extract, Sea Whip Extract, Boswellia Serrata Extract, Honey Extract (Extrait de Miel), Tetrapeptide-14, 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, Glycine Soja (Soybean) Oil, Sodium Oleate, Squalane, Hydrogenated Lecithin, Synthetic Wax, C20-40 Pareth-10, Polyquaternium-67, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Pentylene Glycol, Hydroxyethyl Behenamidopropyl Dimonium Chloride, Sodium Hydroxide, Disodium EDTA, Ethylhexylglycerin, Sodium Benzoate, 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

DISTRIBUTED IN CANADA BY

ALUMIER LABS INC.,

436 LIMESTONE CRESCENT

TORONTO, ON, M3J 2S4

DISTRIBUTED IN THE USA BY

ALUMIER LABS INC.,

550 COCHITUATE ROAD, SUITE 25

FRAMINGHAM, MA 01701

MANUFACTURED IN CANADA UNDER

LICENSE FROM ALUMIER EUROPE LTD.

Product Packaging - 236 mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Alumier MD

Intensive Recovery

Anti-Itch Cream

NPN 80065215

236 mL / 8 fl oz

intensive recoveryintensive recovery

Products#

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

DailyMed product names page 1 of 2 · 48 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69473-00469473-004-01

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 45 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
8de53a10-c370-3bb3-e053-2995a90a974788dbd396-8950-271e-e053-2995a90a0a7a2019-07-17WarningsExact identifier
spl set id: 88dbd396-8950-271e-e053-2995a90a0a7a

Reported adverse events (FAERS/openFDA)#

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