Alumier MD Lightening Lotion

Manufacturer
Alumier Labs
Effective date
2019-05-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:19:38

Label at a glance#

ProductAlumier MD Lightening
Active ingredientHYDROQUINONE
Label structure9 sections

Dosage and administration

adults: apply a small amount as a thin layer on the affected area twice dally, or use as directed by a doctor (physician). If no improvement Is seen after 3 months of treatment, use of this product should be discontinued. Lightening effect of this product may not be noticeable when used on very dark skin. Children uider 12 years of age : do not use unless directed by a doctor. Sunscreen use is an essential aspect ...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydroquinone 2.0%

Purpose

OTC - PURPOSE SECTION

Skin lightener

Use

INDICATIONS & USAGE SECTION

  • for the gradual fading/lightening of dark (browning) discoloration in the skin such as freckles, age and liver spots, pigment in the skin that may occur during pregnancy (for use only after childbirth and only if not breastfeeding) or from the use of oral contraceptives

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults: apply a small amount as a thin layer on the affected area twice dally, or use as directed by a doctor (physician). If no improvement Is seen after 3 months of treatment, use of this product should be discontinued. Lightening effect of this product may not be noticeable when used on very dark skin. Children uider 12 years of age: do not use unless directed by a doctor. Sunscreen use is an essential aspect of hydroquinone therapy because even minimal sunlight exposure may cause skin re-darkening. Sun exposure should be limited by applying (using) a sunscreen SPF 15 or higher or protective clothing to cover bleached skin when using and after using ths product in order to prevent darkening from reoccurring.

Warnings

WARNINGS SECTION

  • for external use only
  • avoid contact with eyes or mucous membranes. In case of contact, rinse thoroughly with water
  • a mild transient stinging or minor redness may occur in people with sensitive skin
  • hydroquinone is a skin bleaching agent which may produce unwanted cosmetic effects if not used as directed
  • apply only to small skin surface areas and limit treatment to relatively small skin surface areas of the body at one time
  • to be used only on the advice of a physician. The physician should be familiar with the information on this label (in this insert) before prescribing or dispensing this product. Close patient supervision is recommended.
  • use only as directed
  • do not apply over sunbum or broken skin
  • in case of accidental ingestion, seek medical assistance or contact Poison Control Center immediately
  • a bitter taste and anesthetic effect may occur If applied to lips
  • Test for sensitivity: To test tor sensitivity, apply to an area of approximately 1 cm of unbroken skin on the inside of the arm. If no irritation occurs within 24 hours, begin treatment for up to 12 weeks.
  • wash your hand thoroughly after applying hydroquinone unless your hands are the treated area
  • Note: Slight darkening of the product is normal when exposed to air and does not affect its potency. (When this happens, extract a tiny amount of product, clean with a cotton swab and discard prior to use.) If entire content becomes brown, discontriue use and consult a physician.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • keep out of the reach of children

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Behenyl Alcohol, BHT, Butylene Glycol, Caprylic Acid, Caprylyl Glycol, Carbomer, Cetearyl Alcohol, Cetearyl Glucoside, Citric Acid, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Root Extract, Hydrogenated Lecithin, Lentinus Edodes Mycelium Extract, Neopentyl Glycol Dicaprylate/Dicaprate, Polyglyceryl-6 Palmitate/Succinate, Propanediol, Sodium Hydroxide, Sodium Metabisulfite, Sodium Sulfite, Sorbitan Stearate, Tocopherol, Tridecyl Stearate, Tridecyl Trimellitate, Trimethylpentanediol/Adipic Acid Copolymer, Water/Aqua/Eau, Xanthan Gum, Xylitol.

Other Information

OTHER SAFETY 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

Company Information

SPL UNCLASSIFIED SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Alumier MD

Lightening Lotion

HYDROQUINONE 2%

FOR GRADUAL FADING OF SKIN DISCOLORATION

NPN: 80062530

50 mL / 1.7 fl oz

lightening lotionlightening lotion

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69473-00569473-005-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d5672dbc-a241-ae2b-e053-2a95a90a7b4e88ddf8be-a8c8-1043-e053-2a95a90a32bc2022-01-12WarningsExact identifier
spl set id: 88ddf8be-a8c8-1043-e053-2a95a90a32bc

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.