Label: ALUMIER MD POST PROCEDURE KIT WITH HYDROCORTISONE- titanium dioxide, zinc oxide, hydrocortisone kit

  • NDC Code(s): 69473-006-04, 69473-017-02, 69473-018-01
  • Packager: Alumier Labs
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 30, 2023

If you are a consumer or patient please visit this version.

  • Drug Facts - Intensive Recovery

  • Active Ingredient

    Hydrocortisone 1.0%

  • Purpose

    Anti-itch cream

  • 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.
  • Warnings

    • For external use only

    • do not use for the treatment of diaper rash, except on the advise of a physician

    When using this product

    • avoid contact with eyes, do not use in or around the eyes

    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.

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

  • 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
  • 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., 550 Cochituate Road, Suite 25, Framingham, MA 01701
  • Inactive Ingredients

    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.

  • Drug Facts - Sheer Hydration

  • Active Ingredients

    Titanium Dioxide 7%

    Zinc Oxide 6.28%

  • Purpose

    Sunscreen

  • Use

    • helps prevent sunburn
  • Warnings

    • For external use only

    When using this product

    • do not use on damaged or broken skin
    • keep out of eyes. Rinse with water to remove.

    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

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

  • Directions

    • 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

    • 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

    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

    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

    insideboxbox

  • INGREDIENTS AND APPEARANCE
    ALUMIER MD POST PROCEDURE KIT WITH HYDROCORTISONE 
    titanium dioxide, zinc oxide, hydrocortisone kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69473-018
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69473-018-011 in 1 CARTON; Type 0: Not a Combination Product03/22/2022
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 15 mL
    Part 21 TUBE 15 mL
    Part 31 TUBE 15 mL
    Part 1 of 3
    ALUMIER MD SHEER HYDRATION 
    titanium dioxide, zinc oxide lotion
    Product Information
    Item Code (Source)NDC:69473-006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE62.8 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE70 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    ACACIA (UNII: 5C5403N26O)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    HYDROXYETHYL BEHENAMIDOPROPYL DIMONIUM CHLORIDE (UNII: 9CO8OUL4TH)  
    MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
    C20-40 PARETH-10 (UNII: TE3MZI4V3F)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    VITIS VINIFERA SEED (UNII: C34U15ICXA)  
    ALUMINUM MONOSTEARATE (UNII: P9BC99461E)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    GLUTATHIONE (UNII: GAN16C9B8O)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    RESVERATROL (UNII: Q369O8926L)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    SYNTHETIC WAX (1800 MW) (UNII: 248P1AUJ90)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69473-006-0415 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02003/22/2022
    Part 2 of 3
    ALUMIER MD INTENSIVE RECOVERY 
    hydrocortisone cream
    Product Information
    Item Code (Source)NDC:69473-017
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    HONEY (UNII: Y9H1V576FH)  
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TRICAPRYLIN (UNII: 6P92858988)  
    ASPALATHUS LINEARIS WHOLE (UNII: O17JQA1A9Z)  
    .BETA.-THUJAPLICIN (UNII: U5335D6EBI)  
    LAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)  
    CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
    PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5)  
    APPLE (UNII: B423VGH5S9)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CRANBERRY (UNII: 0MVO31Q3QS)  
    SQUALANE (UNII: GW89575KF9)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    JOJOBA OIL (UNII: 724GKU717M)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    WATER (UNII: 059QF0KO0R)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    SODIUM METHYL STEAROYL TAURATE (UNII: JFM219LJ55)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    RESVERATROL (UNII: Q369O8926L)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    MENTHA SPICATA (UNII: O2H83I4PUN)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    CAPRYLIC ACID (UNII: OBL58JN025)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PREZATIDE COPPER (UNII: 6BJQ43T1I9)  
    ROSEMARY (UNII: IJ67X351P9)  
    XYLITOL (UNII: VCQ006KQ1E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69473-017-0215 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01703/22/2022
    Part 3 of 3
    ALUMIER MD SENSICALM 
    cleansing (cold creams, cleansing lotions, liquids, and pads) cream
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRMEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    INGRCETYL ALCOHOL (UNII: 936JST6JCN)  
    INGRNIACINAMIDE (UNII: 25X51I8RD4)  
    INGRALLANTOIN (UNII: 344S277G0Z)  
    INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    INGRP-ANISIC ACID (UNII: 4SB6Y7DMM3)  
    INGRXANTHAN GUM (UNII: TTV12P4NEE)  
    INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
    INGRCAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)  
    INGRXYLITOL (UNII: VCQ006KQ1E)  
    INGRCAPRYLIC ACID (UNII: OBL58JN025)  
    INGR4-TERPINEOL, (+/-)- (UNII: L65MV77ZG6)  
    INGREDETATE SODIUM (UNII: MP1J8420LU)  
    INGREDETATE DISODIUM (UNII: 7FLD91C86K)  
    INGRWATER (UNII: 059QF0KO0R)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRPROPANEDIOL (UNII: 5965N8W85T)  
    INGRCOCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)  
    INGRSODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
    INGRALOE VERA LEAF (UNII: ZY81Z83H0X)  
    INGRYUCCA SCHIDIGERA ROOT (UNII: E2H9ET15AT)  
    INGRSUNFLOWER OIL (UNII: 3W1JG795YI)  
    INGRLINALYL ACETATE (UNII: 5K47SSQ51G)  
    INGR.BETA.-OCIMENE, (3Z)- (UNII: 472UVP4R7T)  
    INGRDISODIUM COCOYL GLUTAMATE (UNII: MBK0CP8F5A)  
    INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    INGRLINALOOL, (+/-)- (UNII: D81QY6I88E)  
    INGRSODIUM CHLORIDE (UNII: 451W47IQ8X)  
    INGRSORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    INGRCERAMIDE NG (UNII: C04977SRJ5)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    115 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic11/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01703/22/2022
    Labeler - Alumier Labs (079603173)