Label: ALUMIER MD INTENSIVE RECOVERY- hydrocortisone cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated March 8, 2022

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  • Drug Facts

  • 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 advice 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, Propanediol, Butyrospermum Parkii (Shea Butter), Simmondsia Chinensis (Jojoba) Seed Oil, Glycerin, Dimethicone, Caprylic/Capric Triglyceride, Butylene Glycol, 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.

  • Company Information

    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

    Alumier MD

    Intensive Recovery

    Anti-Itch Cream

    NPN 80065215

    236 mL / 8 fl oz

    intensive recovery rev

  • INGREDIENTS AND APPEARANCE
    ALUMIER MD INTENSIVE RECOVERY 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem 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
    DOCOSANOL (UNII: 9G1OE216XY)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    TRICAPRYLIN (UNII: 6P92858988)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    XYLITOL (UNII: VCQ006KQ1E)  
    HONEY (UNII: Y9H1V576FH)  
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
    MENTHA SPICATA (UNII: O2H83I4PUN)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    JOJOBA OIL (UNII: 724GKU717M)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    WATER (UNII: 059QF0KO0R)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    .BETA.-THUJAPLICIN (UNII: U5335D6EBI)  
    RESVERATROL (UNII: Q369O8926L)  
    PREZATIDE COPPER (UNII: 6BJQ43T1I9)  
    LAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)  
    CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
    PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    APPLE (UNII: B423VGH5S9)  
    ROSEMARY (UNII: IJ67X351P9)  
    CRANBERRY (UNII: 0MVO31Q3QS)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    ASPALATHUS LINEARIS WHOLE (UNII: O17JQA1A9Z)  
    SQUALANE (UNII: GW89575KF9)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CAPRYLIC ACID (UNII: OBL58JN025)  
    SODIUM METHYL STEAROYL TAURATE (UNII: JFM219LJ55)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69473-017-011 in 1 CARTON03/08/2022
    1236 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/08/2022
    Labeler - Alumier Labs (079603173)
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