ALUMIER MD POST PROCEDURE PRESCRIPTION- titanium dioxide, zinc oxide, hydrocortisone acetate kit

Alumier MD Post Procedure Prescription by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Facts - Intensive Recovery

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, 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, 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.

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

Alumier MD

Post Procedure Prescription

3 STEPS. 5 DAYS TO GLOWING SKIN.

With Hydrocortisone

INGREDIENTS AND APPEARANCE

ALUMIER MD POST PROCEDURE PRESCRIPTION 
titanium dioxide, zinc oxide, hydrocortisone acetate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69473-007

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69473-007-01	1 in 1 CARTON; Type 0: Not a Combination Product	07/01/2019

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 INTENSIVE RECOVERY 
hydrocortisone acetate cream

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE ACETATE	11.2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
HONEY (UNII: Y9H1V576FH)
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
PEG-100 STEARATE (UNII: YD01N1999R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
STEARETH-21 (UNII: 53J3F32P58)
ASPALATHUS LINEARIS WHOLE (UNII: O17JQA1A9Z)
SOYBEAN OIL (UNII: 241ATL177A)
.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)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM OLEATE (UNII: 399SL044HN)
SQUALANE (UNII: GW89575KF9)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
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)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
NIACINAMIDE (UNII: 25X51I8RD4)
RESVERATROL (UNII: Q369O8926L)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
C20-40 PARETH-10 (UNII: TE3MZI4V3F)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
MENTHA SPICATA (UNII: O2H83I4PUN)
HYDROXYETHYL BEHENAMIDOPROPYL DIMONIUM CHLORIDE (UNII: 9CO8OUL4TH)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
COCOA BUTTER (UNII: 512OYT1CRR)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PREZATIDE COPPER (UNII: 6BJQ43T1I9)
ROSEMARY (UNII: IJ67X351P9)

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
OTC monograph not final	part348	07/01/2019

Part 2 of 3

ALUMIER MD SHEER HYDRATION 
titanium dioxide, zinc oxide lotion

Product Information
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
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
WATER (UNII: 059QF0KO0R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ACACIA (UNII: 5C5403N26O)
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)

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
OTC monograph not final	part352	07/01/2019

Part 3 of 3

ALUMIER MD SENSICALM 
cleansing (cold creams, cleansing lotions, liquids, and pads) cream

Product 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		07/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/01/2019

Labeler - Alumier Labs (079603173)