Alumier Md Intensive Recovery

Alumier Md Intensive Recovery
SPL v3
SPL
SPL Set ID d9b79ea1-6558-543c-e053-2995a90ae53e
Route
TOPICAL
Published
Effective Date 2019-05-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (10 mg)
Inactive Ingredients
Ceramide Np Ceramide Ng Lecithin, Soybean Hydrogenated Soybean Lecithin Tricaprylin Caprylyl Glycol Xylitol Honey Edetic Acid Sodium Hydroxide Jojoba Oil Water Shea Butter Medium-chain Triglycerides Glycerin Dimethicone Propanediol Cocoa Butter Aloe Vera Leaf Niacinamide Resveratrol Indian Frankincense Squalane Ethylhexylglycerin Poly(methyl Methacrylate; 450000 Mw) Xanthan Gum Caprylic Acid Sodium Methyl Stearoyl Taurate Copper Tripeptide-1 Wolfiporia Cocos Sclerotium Behenyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-03-08

Description

Hydrocortisone 1.0%

Purpose

Anti-itch cream


Medication Information

Purpose

Anti-itch cream

Description

Hydrocortisone 1.0%

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.
Section 50565-1

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

Section 50566-9

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.

Section 50567-7

When using this product

  • avoid contact with eyes, do not use in or around the eyes
Section 50570-1
  • do not use for the treatment of diaper rash, except on the advice of a physician
Warnings
  • For external use only.
Directions
  • 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
Product Labeling

Active Ingredient

Hydrocortisone 1.0%

Other 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., 945 Concord Street, Framingham, MA 01701
Non Medicinal Ingredients

Water/Aqua/Eau, Propanediol, Butyrospermum Parkii (Shea Butter), Simmondsia Chinensis (Jojoba) Seed Oil, Glycerin, Caprylic/Capric Triglyceride, Dimethicone, Propanediol, Theobroma Cacao (Cocoa) Seed Butter, Aloe Barbadensis Leaf Juice, Niacinamide, Resveratrol, Poria Cocos Sclerotium Extract, Boswellia Serrata Gum Extract, Honey Extract (Extrait de miel), Tetrapeptide-14, Copper Tripeptide-1, Aspalathus Linearis Extract, Ceramide NP, Ceramide NG, Squalane, Hydrogenated Lecithin, Sodium Acrylates Copolymer, Lecithin, Behenyl Alcohol, Xanthan Gum, Caprylic Acid, Sodium Methyl Stearoyl Taurate, Tricaprylin, Polymethyl Methacrylate, Sodium Hydroxide, Disodium EDTA, Caprylyl Glycol, Xylitol, Ethylhexylglycerin.


Structured Label Content

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.
Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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.

Section 50567-7 (50567-7)

When using this product

  • avoid contact with eyes, do not use in or around the eyes
Section 50570-1 (50570-1)
  • do not use for the treatment of diaper rash, except on the advice of a physician
Purpose

Anti-itch cream

Warnings
  • For external use only.
Directions
  • 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
Product Labeling

Active Ingredient

Hydrocortisone 1.0%

Other 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., 945 Concord Street, Framingham, MA 01701
Non Medicinal Ingredients (Non-medicinal ingredients)

Water/Aqua/Eau, Propanediol, Butyrospermum Parkii (Shea Butter), Simmondsia Chinensis (Jojoba) Seed Oil, Glycerin, Caprylic/Capric Triglyceride, Dimethicone, Propanediol, Theobroma Cacao (Cocoa) Seed Butter, Aloe Barbadensis Leaf Juice, Niacinamide, Resveratrol, Poria Cocos Sclerotium Extract, Boswellia Serrata Gum Extract, Honey Extract (Extrait de miel), Tetrapeptide-14, Copper Tripeptide-1, Aspalathus Linearis Extract, Ceramide NP, Ceramide NG, Squalane, Hydrogenated Lecithin, Sodium Acrylates Copolymer, Lecithin, Behenyl Alcohol, Xanthan Gum, Caprylic Acid, Sodium Methyl Stearoyl Taurate, Tricaprylin, Polymethyl Methacrylate, Sodium Hydroxide, Disodium EDTA, Caprylyl Glycol, Xylitol, Ethylhexylglycerin.


Advanced Ingredient Data


Raw Label Data

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