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
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- Official Label (Printer Friendly)
- Drug Facts - Intensive Recovery
- Active Ingredient
- Purpose
-
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
- Directions
- Other Information
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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
- Purpose
- Use
- Warnings
-
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
-
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
- Product Packaging
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INGREDIENTS AND APPEARANCE
ALUMIER MD POST PROCEDURE KIT WITH HYDROCORTISONE
titanium dioxide, zinc oxide, hydrocortisone kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69473-018 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69473-018-01 1 in 1 CARTON; Type 0: Not a Combination Product 03/22/2022 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 TUBE 15 mL Part 2 1 TUBE 15 mL Part 3 1 TUBE 15 mL Part 1 of 3 ALUMIER MD SHEER HYDRATION
titanium dioxide, zinc oxide lotionProduct Information Item Code (Source) NDC:69473-006 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 62.8 mg in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 70 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:69473-006-04 15 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 M020 03/22/2022 Part 2 of 3 ALUMIER MD INTENSIVE RECOVERY
hydrocortisone creamProduct Information 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 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:69473-017-02 15 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 03/22/2022 Part 3 of 3 ALUMIER MD SENSICALM
cleansing (cold creams, cleansing lotions, liquids, and pads) creamProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) INGR CETYL ALCOHOL (UNII: 936JST6JCN) INGR NIACINAMIDE (UNII: 25X51I8RD4) INGR ALLANTOIN (UNII: 344S277G0Z) INGR .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) INGR P-ANISIC ACID (UNII: 4SB6Y7DMM3) INGR XANTHAN GUM (UNII: TTV12P4NEE) INGR SODIUM HYDROXIDE (UNII: 55X04QC32I) INGR CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0) INGR XYLITOL (UNII: VCQ006KQ1E) INGR CAPRYLIC ACID (UNII: OBL58JN025) INGR 4-TERPINEOL, (+/-)- (UNII: L65MV77ZG6) INGR EDETATE SODIUM (UNII: MP1J8420LU) INGR EDETATE DISODIUM (UNII: 7FLD91C86K) INGR WATER (UNII: 059QF0KO0R) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR PROPANEDIOL (UNII: 5965N8W85T) INGR COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W) INGR SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX) INGR ALOE VERA LEAF (UNII: ZY81Z83H0X) INGR YUCCA SCHIDIGERA ROOT (UNII: E2H9ET15AT) INGR SUNFLOWER OIL (UNII: 3W1JG795YI) INGR LINALYL ACETATE (UNII: 5K47SSQ51G) INGR .BETA.-OCIMENE, (3Z)- (UNII: 472UVP4R7T) INGR DISODIUM COCOYL GLUTAMATE (UNII: MBK0CP8F5A) INGR CAPRYLYL GLYCOL (UNII: 00YIU5438U) INGR LINALOOL, (+/-)- (UNII: D81QY6I88E) INGR SODIUM CHLORIDE (UNII: 451W47IQ8X) INGR SORBITAN MONOOLEATE (UNII: 06XEA2VD56) INGR CERAMIDE NG (UNII: C04977SRJ5) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 15 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 Cosmetic 11/20/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 03/22/2022 Labeler - Alumier Labs (079603173)