ALUMIER MD INTENSIVE RECOVERY- hydrocortisone acetate cream 
Alumier Labs

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.

----------

Alumier MD Intensive Recovery

Drug Facts

Active Ingredient

Hydrocortisone (Hydrocortisone acetate) 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, poson 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 ocndition 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, Caprylic/Capric Triglyceride, Butylene Glycol, Glycerin, Dimethicone, Propanediol, Theobroma Cacao (Cocoa) Seed Butter, Cetearyl Alcohol, Cyclopentasiloxane, Glyceryl Stearate, PEG-100 Stearate, Ceteareth-20, Aloe Barbadensis Leaf Juice, Niacinamide, Steareth-21, Hinokitiol, Resveratrol, Copper Tripeptide-1, Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract, Anthemis Nobilis Flower Extract, Sea Whip Extract, Boswellia Serrata Extract, Honey Extract (Extrait de Miel), Tetrapeptide-14, 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, Glycine Soja (Soybean) Oil, Sodium Oleate, Squalane, Hydrogenated Lecithin, Synthetic Wax, C20-40 Pareth-10, Polyquaternium-67, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Pentylene Glycol, Hydroxyethyl Behenamidopropyl Dimonium Chloride, Sodium Hydroxide, Disodium EDTA, Ethylhexylglycerin, Sodium Benzoate, 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

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

ALUMIER MD INTENSIVE RECOVERY 
hydrocortisone acetate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69473-008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE11.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
HONEY (UNII: Y9H1V576FH)  
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
MENTHA SPICATA (UNII: O2H83I4PUN)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
HYDROXYETHYL BEHENAMIDOPROPYL DIMONIUM CHLORIDE (UNII: 9CO8OUL4TH)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
JOJOBA OIL (UNII: 724GKU717M)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
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)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
NIACINAMIDE (UNII: 25X51I8RD4)  
STEARETH-21 (UNII: 53J3F32P58)  
.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)  
C20-40 PARETH-10 (UNII: TE3MZI4V3F)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
ASPALATHUS LINEARIS WHOLE (UNII: O17JQA1A9Z)  
SOYBEAN OIL (UNII: 241ATL177A)  
SODIUM OLEATE (UNII: 399SL044HN)  
SQUALANE (UNII: GW89575KF9)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69473-008-011 in 1 CARTON07/01/2019
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 finalpart34807/01/201910/31/2020
Labeler - Alumier Labs (079603173)

Revised: 3/2022
Document Id: d9b7f273-9902-3786-e053-2995a90ad0e2
Set id: 89555a44-fe53-0f6a-e053-2995a90a561f
Version: 2
Effective Time: 20220308
 
Alumier Labs