Alumier MD Post Procedure Kit with Hydrocortisone

Manufacturer
Alumier Labs
Effective date
2024-10-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:29:49

Label at a glance#

ProductAlumier MD Post Procedure Kit with Hydrocortisone
Active ingredientZINC OXIDE, TITANIUM DIOXIDE, HYDROCORTISONE
Label structure8 sections

Indications and 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.

Dosage and administration

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...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Clear Shield:

Titanium Dioxide 7%

Zinc Oxide 6.18%

Intensive Recovery:

Hydrocortisone 1.0%

Purpose

OTC - PURPOSE SECTION

Clear Shield:

Sunscreen

Intensive Recovery:

Anti-itch cream

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

Clear Shield:

  • on broken skin

Intensive Recovery:

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

When using this product

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

OTHER SAFETY 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

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

22

22

22

11

11

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
106258hydrocortisone 1 % Topical CreamPSN1
106258hydrocortisone 10 MG/ML Topical CreamSCD1
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSY1
106258hydrocortisone 1 % Topical CreamSY1
106258hydrocortisone 1 GM per 100 GM Topical CreamSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
HYDROCORTISONE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
15bd4439-874a-4934-9954-248e5455d460Product name120260310
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777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
4d56e8eb-d741-d4a5-de3f-2bab1af75a60Product name720220608
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
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
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1Product name220150218
02657a3f-1489-66ea-f740-5ab9524e57d7Product name120140508
26f3d783-2cc1-4327-e77d-71804cf675a2Product name120140508
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61e59a42-186b-9f4b-aec3-fb49a6debc31Product name120140508
705740e1-dee5-2610-c5a3-4c59cd9d62afProduct name120140508
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
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b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
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da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69473-020-01Alumier MD Post Procedure Kit with Hydrocortisone1 in 1 CARTONKIT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69473-020ALUMIER MD POST PROCEDURE KIT WITH HYDROCORTISONE (TITANIUM DIOXIDE, ZINC OXIDE, HYDROCORTISONE) KIT [ALUMIER LABS]1Current NDC, 1 package rows20241027_2551d748-c3d6-cd18-e063-6294a90adab6.zip

Products#

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

DailyMed product names page 1 of 3 · 91 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69473-02069473-020-01
69473-011
69473-017

Ingredients#

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

DailyMed ingredient rows page 1 of 3 · 113 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 Clear Shield Broad Spectrum SPF 42 SunscreenTITANIUM DIOXIDE, ZINC OXIDEAlumier Labsa9c970c8-b6e3-b0a1-e053-2a95a90a89c72026-02-09WarningsExact identifier
ndc (product): 69473-011
Alumier MD Intensive RecoveryHYDROCORTISONEAlumier Labsd9b79ea1-6558-543c-e053-2995a90ae53e2025-08-06WarningsExact identifier
ndc (product): 69473-017
Alumier MD Post Procedure Kit with HydrocortisoneTITANIUM DIOXIDE, ZINC OXIDE, HYDROCORTISONEAlumier Labs2551d748-c3d6-cd18-e063-6294a90adab62024-10-25WarningsExact identifier
ndc (package): 69473-020-01
ndc (product): 69473-020
ndc11 (package): 69473002001
spl id: 2551d9c3-b0ce-c683-e063-6294a90ad978
spl set id: 2551d748-c3d6-cd18-e063-6294a90adab6

Reported adverse events (FAERS/openFDA)#

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