alumier md acne balancing serum

alumier md acne balancing serum
SPL v3
SPL
SPL Set ID 87eb6adc-c38e-d7df-e053-2a95a90aa747
Route
topical
Published
Effective Date 2019-05-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
salicylic acid (20 mg)
Inactive Ingredients
allantoin aloe vera leaf caprylic acid edetic acid hyaluronate sodium resveratrol xanthan gum tricaprylin xylitol propanediol water dimethyl isosorbide indian frankincense caprylyl glycol oligopeptide-10 honey glycerin ammonium acryloyldimethyltaurate/vp copolymer poly(methyl methacrylate; 450000 mw) sodium phosphate rice bran niacinamide glyceryl caprate tocopherol sodium hydroxide ethylhexylglycerin .beta.-thujaplicin fu ling hydrated silica disodium phosphate cetyl hydroxyethylcellulose (350000 mw) silica dimethyl silylate

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

For Adults 18 years and older

  • cleanse skin thoroughly before applying the product

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
  • Store in a cool, dry place at room temperature
  • You may report a serious adverse reaction event from using this product to: Alumier Labs Inc., 945 Concord Street, Framingham, MA 01701
Inactive Ingredients

Water/Aqua/Eau, Propanediol, Dimethyl Isosorbide, Glyceryl Caprate, Niacinamide, Poria Cocos Extract, Hinokitiol, Oryza Sativa (Rice) Bran Extract, Boswellia Serrata Gum Extract, Aloe Barbadensis Leaf Juice, Caprylic Acid, Caprylyl Glycol, Sodium Hyaluronate, Glycerin, Resveratrol, Oligopeptide-10, Honey Extract (Extrait de Miel), Allantoin, Disodium EDTA, Ammonium Acryloyldimethyltaurate/VP Copolymer, Allyl Methacrylates Crosspolymer, Xanthan Gum, Cetyl Hydroxyethylcellulose, Polymethyl Methacrylate, Tricaprylin, Sodium Hydroxide, Xylitol, Hydrated Silica, Disodium Phosphate, Silica Dimethyl Silylate, Sodium Phosphate, Tocopherol, Ethylhexylglycerin.

Description

Salicylic Acid 2.0%

Use
  • for the treatment of acne
Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center 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
  • have severe acne, and/or iimprovement is not apparent within 6-8 weeks
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.
Product Labeling

Active Ingredient

Salicylic Acid 2.0%


Structured Label Content

Warnings
  • For external use only.
Purpose

Acne treatment

Directions

For Adults 18 years and older

  • cleanse skin thoroughly before applying the product

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 (Other information)
  • Do not use if security seal is broken or missing
  • Store in a cool, dry place at room temperature
  • You may report a serious adverse reaction event from using this product to: Alumier Labs Inc., 945 Concord Street, Framingham, MA 01701
Inactive Ingredients

Water/Aqua/Eau, Propanediol, Dimethyl Isosorbide, Glyceryl Caprate, Niacinamide, Poria Cocos Extract, Hinokitiol, Oryza Sativa (Rice) Bran Extract, Boswellia Serrata Gum Extract, Aloe Barbadensis Leaf Juice, Caprylic Acid, Caprylyl Glycol, Sodium Hyaluronate, Glycerin, Resveratrol, Oligopeptide-10, Honey Extract (Extrait de Miel), Allantoin, Disodium EDTA, Ammonium Acryloyldimethyltaurate/VP Copolymer, Allyl Methacrylates Crosspolymer, Xanthan Gum, Cetyl Hydroxyethylcellulose, Polymethyl Methacrylate, Tricaprylin, Sodium Hydroxide, Xylitol, Hydrated Silica, Disodium Phosphate, Silica Dimethyl Silylate, Sodium Phosphate, Tocopherol, Ethylhexylglycerin.

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center 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
  • have severe acne, and/or iimprovement is not apparent within 6-8 weeks
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.
Product Labeling

Active Ingredient (Active ingredient)

Salicylic Acid 2.0%


Advanced Ingredient Data


Raw Label Data

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