alumier md acne clarifying cleanser

alumier md acne clarifying cleanser
SPL v3
SPL
SPL Set ID 87747f82-9018-ab34-e053-2995a90a6808
Route
topical
Published
Effective Date 2019-04-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
salicylic acid (20 mg)
Inactive Ingredients
caprylic acid propanediol cocamidopropyl hydroxysultaine glyceryl caprate oligopeptide-10 honey edetic acid cocamidopropyl dimethylamine aloe vera leaf caprylyl glycol glycerin rice bran carboxypolymethylene sodium hydroxide xylitol ethylhexylglycerin indian frankincense water sodium c14-16 olefin sulfonate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2019-07-01

Purpose

Acne Treatment

Description

Salicylic Acid 2.0%


Medication Information

Warnings
  • For external use only.
Purpose

Acne Treatment

Directions
  • use twice daily, in the morning and evening
  • moisten face with lukewarm water
  • pump a small amount into your hand
  • add water and apply to your face and neck, massaging in a circular motion
  • rinse thoroughly with lukewarm water and gently pat dry

For New Users

  • apply product to a small area once a day for three days to test if you are sensitive to this product
  • if no discomfort occurs, cover the entire affected area with a thin layer
  • start with one application daily, then gradually increase to two to three times daily, if needed
  • if dryness or peeling occurs, reduce application to once a day or every other day
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, Sodium C14-16 Olefin Sulfonate, Propanediol, Dimethyl Lauramide/Myristamide, Glycerin, Cocamidopropyl Dimethylamine, Cocamidopropyl Hydroxysultaine, Glyceryl Caprate, Lauryl Lactyl Lactate, Oligopeptide-10, Aloe Barbadensis Leaf Juice, Boswellia Serrata Gum Extract, Honey Extract (Extrait de Miel), Oryza Sativa (Rice) Bran Extract, Carbomer, Sodium Hydroxide, Disodium EDTA, Caprylyl Glycol, Xylitol, Caprylic Acid, Ethylhexylglycerin.

Description

Salicylic Acid 2.0%

Use
  • for the treatment of acne
Section 50565-1

Keep out of reach of children. If swallowed, call a Poison Control Centre or get medical help right away.

Section 50566-9

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

  • for more severe cases, and/or if improvement is not apparent within 6-8 weeks, consult a health care professional
Section 50567-7

When using this product​

  • avoid contact with eyes. If contact occurs, rinse thoroughly with water.
  • skin irritation and dryness is more likely to occur if you use another topical acne product at the same time. If irritation occurs, only use one topical acne product at a time.
Active Ingredient

Salicylic Acid 2.0%

Product Packaging

Alumier MD

Acne Clarifying Cleanser

ACNE TREATMENT WITH 2%

SALICYLIC ACID

NPN: 80064465

177 mL/6 fl oz

Company Information

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.


Structured Label Content

Warnings
  • For external use only.
Purpose

Acne Treatment

Directions
  • use twice daily, in the morning and evening
  • moisten face with lukewarm water
  • pump a small amount into your hand
  • add water and apply to your face and neck, massaging in a circular motion
  • rinse thoroughly with lukewarm water and gently pat dry

For New Users

  • apply product to a small area once a day for three days to test if you are sensitive to this product
  • if no discomfort occurs, cover the entire affected area with a thin layer
  • start with one application daily, then gradually increase to two to three times daily, if needed
  • if dryness or peeling occurs, reduce application to once a day or every other day
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, Sodium C14-16 Olefin Sulfonate, Propanediol, Dimethyl Lauramide/Myristamide, Glycerin, Cocamidopropyl Dimethylamine, Cocamidopropyl Hydroxysultaine, Glyceryl Caprate, Lauryl Lactyl Lactate, Oligopeptide-10, Aloe Barbadensis Leaf Juice, Boswellia Serrata Gum Extract, Honey Extract (Extrait de Miel), Oryza Sativa (Rice) Bran Extract, Carbomer, Sodium Hydroxide, Disodium EDTA, Caprylyl Glycol, Xylitol, Caprylic Acid, Ethylhexylglycerin.

Use
  • for the treatment of acne
Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, call a Poison Control Centre or get medical help right away.

Section 50566-9 (50566-9)

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

  • for more severe cases, and/or if improvement is not apparent within 6-8 weeks, consult a health care professional
Section 50567-7 (50567-7)

When using this product​

  • avoid contact with eyes. If contact occurs, rinse thoroughly with water.
  • skin irritation and dryness is more likely to occur if you use another topical acne product at the same time. If irritation occurs, only use one topical acne product at a time.
Active Ingredient

Salicylic Acid 2.0%

Product Packaging

Alumier MD

Acne Clarifying Cleanser

ACNE TREATMENT WITH 2%

SALICYLIC ACID

NPN: 80064465

177 mL/6 fl oz

Company Information

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.


Advanced Ingredient Data


Raw Label Data

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