Amino Mask

Amino Mask
SPL v1
SPL
SPL Set ID c133f1cb-2ebf-4606-89f8-b902ee643d43
Route
TOPICAL
Published
Effective Date 2012-04-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sulfur (5 mL)
Inactive Ingredients
Water Kaolin Caprylic/capric Acid Glycerin Cetostearyl Alcohol Polyoxyl 20 Cetostearyl Ether Glyceryl Monostearate Peg-100 Stearate Glycyrrhizinate Dipotassium Lactic Acid Bentonite Chondrus Crispus Titanium Dioxide Lavender Oil Green Tea Leaf Wine Grape Kiwi Fruit Honey Niacinamide Biotin Panthenol Allantoin Phenoxyethanol Ethylhexylglycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-04-26

Description

Active ingredients        Purpose Sulfur 5%                   Acne treatment


Medication Information

Warnings and Precautions

Warnings

For external use only

When using this product:

Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs only use one topical medication at a time.

Apply only to areas with acne

Do not use on:

- Broken Skin

- Large areas of the skin

If swallowed, get medical help or contact a Poison Control Center right away.

Indications and Usage

Stop use and ask a doctor

If skin irritation occurs or gets worse

Do not get into eyes

Dosage and Administration

Directions

Cleanse the Skin thoroughly before applying this product. Cover the entire affected area with a thin layer and let dry 15 minutes then rinse well. Use twice a week. Because excessive drying of the skin may occur, start with one application, then gradually increase to two times a week if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application or discontinue use.

Description

Active ingredients        Purpose Sulfur 5%                   Acne treatment

Section 50565-1

Keep out of reach of children

Section 51727-6


Inactive ingredients

Water (Aqua) (Eau), Kaolin, Caprylic/Capric Triglyceride, Glycerin, Cetearyl Alcohol, Ceteareth-20, Glyceryl Stearate, PEG-100 Stearate, Dipotassium Glycyrrhizate, Lactic Acid, Bentonite, Chondrus Crispus (Carrageenan), Titanium Dioxide (CI 77891), Lavendula Angustifolia (Lavender) Oil, Camellia Sinensis (Green Tea) Leaf Extract, Vitis Vinifera (Grape) Fruit Extract, Actinidia Chinensis (Kiwi) Extract, Mel (Honey) Extract (Miel Extrait de Mile), Niacinamide,  Biotin, Panthenol, Allantoin, Pyroxidine HCL, Hydrolyzed Soy Protein, Phenoxyethanol, Ethylhexylglycerin.







Section 51945-4

Bioelements

Amino Mask (R)

Sulfur Acne Treatment Mask with Lactic Acid

73 mL / 2.5 Fl. Oz.













Section 55105-1

Uses

For the management of acne

Helps prevent acne pimples (and/or acne blemishes, blackheads, whiteheads)



Section 55106-9

Active ingredients        Purpose

Sulfur 5%                   Acne treatment


Structured Label Content

Indications and Usage (34067-9)

Stop use and ask a doctor

If skin irritation occurs or gets worse

Do not get into eyes

Dosage and Administration (34068-7)

Directions

Cleanse the Skin thoroughly before applying this product. Cover the entire affected area with a thin layer and let dry 15 minutes then rinse well. Use twice a week. Because excessive drying of the skin may occur, start with one application, then gradually increase to two times a week if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application or discontinue use.

Warnings and Precautions (34071-1)

Warnings

For external use only

When using this product:

Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs only use one topical medication at a time.

Apply only to areas with acne

Do not use on:

- Broken Skin

- Large areas of the skin

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)


Inactive ingredients

Water (Aqua) (Eau), Kaolin, Caprylic/Capric Triglyceride, Glycerin, Cetearyl Alcohol, Ceteareth-20, Glyceryl Stearate, PEG-100 Stearate, Dipotassium Glycyrrhizate, Lactic Acid, Bentonite, Chondrus Crispus (Carrageenan), Titanium Dioxide (CI 77891), Lavendula Angustifolia (Lavender) Oil, Camellia Sinensis (Green Tea) Leaf Extract, Vitis Vinifera (Grape) Fruit Extract, Actinidia Chinensis (Kiwi) Extract, Mel (Honey) Extract (Miel Extrait de Mile), Niacinamide,  Biotin, Panthenol, Allantoin, Pyroxidine HCL, Hydrolyzed Soy Protein, Phenoxyethanol, Ethylhexylglycerin.







Section 51945-4 (51945-4)

Bioelements

Amino Mask (R)

Sulfur Acne Treatment Mask with Lactic Acid

73 mL / 2.5 Fl. Oz.













Section 55105-1 (55105-1)

Uses

For the management of acne

Helps prevent acne pimples (and/or acne blemishes, blackheads, whiteheads)



Section 55106-9 (55106-9)

Active ingredients        Purpose

Sulfur 5%                   Acne treatment


Advanced Ingredient Data


Raw Label Data

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