Alumier Md Post Procedure Kit With Hydrocortisone

Alumier Md Post Procedure Kit With Hydrocortisone
SPL v1
SPL
SPL Set ID 2551d748-c3d6-cd18-e063-6294a90adab6
Route
TOPICAL
Published
Effective Date 2024-10-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (61.8 mg) Titanium Dioxide (70 mg) Hydrocortisone (10 mg)
Inactive Ingredients
Xylitol Caprylic Acid Ethylhexylglycerin Hyaluronate Sodium Lecithin, Sunflower Polyhydroxystearic Acid (2300 Mw) Butylene Glycol Tricaprylin Glyceryl Monostearate Niacinamide Caprylyl Methicone Polygonum Aviculare Top Triethoxycaprylylsilane Water Acacia Polyoxyl 20 Cetostearyl Ether Ascorbic Acid Butyloctyl Salicylate Glycerin Vitis Vinifera Seed Aluminum Monostearate Medium-chain Triglycerides Xanthan Gum Alkyl (c12-15) Benzoate Propanediol Carboxymethylcellulose Sodium, Unspecified Form .alpha.-tocopherol Acetate Microcrystalline Cellulose Edetic Acid Cetostearyl Alcohol Peg-100 Stearate Aluminum Oxide Glutathione Phenoxyethanol Resveratrol Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Tocopherol Physalis Angulata Poly(methyl Methacrylate; 450000 Mw) Sodium Benzoate Dimethicone Caprylyl Glycol Pentylene Glycol Potassium Sorbate Docosanol Cocoa Butter Prezatide Copper Indian Frankincense Honey Edetate Disodium Sodium Methyl Stearoyl Taurate Shea Butter Jojoba Oil Aspalathus Linearis Leaf Squalane Aloe Vera Leaf Sodium Hydroxide Hydrogenated Soybean Lecithin Ceramide Np Ceramide Ng

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-10-25

Description

Clear Shield: Titanium Dioxide 7% Zinc Oxide 6.18% Intensive Recovery: Hydrocortisone 1.0%

Purpose

Clear Shield: Sunscreen Intensive Recovery: Anti-itch cream


Medication Information

Purpose

Clear Shield:

Sunscreen

Intensive Recovery:

Anti-itch cream

Description

Clear Shield: Titanium Dioxide 7% Zinc Oxide 6.18% Intensive Recovery: Hydrocortisone 1.0%

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

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
Do Not Use

Clear Shield:

  • on broken skin

Intensive Recovery:

  • for the treatment of diaper rash, except on the advice of 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
Product Packaging

Active Ingredients

Clear Shield:

Titanium Dioxide 7%

Zinc Oxide 6.18%

Intensive Recovery:

Hydrocortisone 1.0%

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
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.

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.


Structured Label Content

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.
Purpose

Clear Shield:

Sunscreen

Intensive Recovery:

Anti-itch cream

Warnings

For external use only

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
Do Not Use (Do not use)

Clear Shield:

  • on broken skin

Intensive Recovery:

  • for the treatment of diaper rash, except on the advice of 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
Product Packaging

Active Ingredients

Clear Shield:

Titanium Dioxide 7%

Zinc Oxide 6.18%

Intensive Recovery:

Hydrocortisone 1.0%

When Using This Product (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
Non Medicinal Ingredients (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.

Stop Use and Ask A Doctor (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 (Keep out of reach of children)

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


Advanced Ingredient Data


Raw Label Data

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