ALUMIER MD INTENSIVE RECOVERY- hydrocortisone cream

Alumier MD Intensive Recovery by

Drug Labeling and Warnings

Alumier MD Intensive Recovery by is a Otc medication manufactured, distributed, or labeled by Alumier Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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., 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.

Product Labeling

INGREDIENTS AND APPEARANCE

ALUMIER MD INTENSIVE RECOVERY 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69473-017
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CERAMIDE NP (UNII: 4370DF050B)
CERAMIDE NG (UNII: C04977SRJ5)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
TRICAPRYLIN (UNII: 6P92858988)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
XYLITOL (UNII: VCQ006KQ1E)
HONEY (UNII: Y9H1V576FH)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
JOJOBA OIL (UNII: 724GKU717M)
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)
RESVERATROL (UNII: Q369O8926L)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
SQUALANE (UNII: GW89575KF9)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
XANTHAN GUM (UNII: TTV12P4NEE)
CAPRYLIC ACID (UNII: OBL58JN025)
SODIUM METHYL STEAROYL TAURATE (UNII: JFM219LJ55)
COPPER TRIPEPTIDE-1 (UNII: 6BJQ43T1I9)
WOLFIPORIA COCOS SCLEROTIUM (UNII: MTD53229ZC)
BEHENYL ALCOHOL (UNII: 9G1OE216XY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69473-017-01	1 in 1 CARTON	03/08/2022
1		236 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	03/08/2022

Labeler - Alumier Labs (079603173)