Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 1bbea19a-cba7-4d6a-aefa-c09b000e7631
Route
TOPICAL
Published
Effective Date 2010-08-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (25 mg)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2010-01-01

Description

INDICATIONS AND USAGE: Formulated as a home treatment for acne-prone skin, this mask gently exfoliates the skin's surface with jojoba beads, allowing the follicular-oxidizing benefits of Benzoyl Peroxide to penetrate and take effect. Plant extracts and MSM are also included to increase healing time and assist in preventing future breakouts. DIRECTIONS: Apply to cleansed skin using fingertips. Massage gently in circular movements for 1-2 minutes and then allow the product to remain on the skin for an additional 5-10 minutes, depending on skin tolerance and/or sensitivity. Avoid the eye area. Rinse well and follow suggested post-mark home care reigimen. Use this product according the recommendations of your skin care professional. Skip the massage step with Grade 3 and 4 Acne.


Medication Information

Indications and Usage

INDICATIONS AND USAGE:

Formulated as a home treatment for acne-prone skin, this mask gently exfoliates the skin's surface with jojoba beads, allowing the follicular-oxidizing benefits of Benzoyl Peroxide to penetrate and take effect. Plant extracts and MSM are also included to increase healing time and assist in preventing future breakouts.



DIRECTIONS:



Apply to cleansed skin using fingertips. Massage gently in circular movements for 1-2 minutes and then allow the product to remain on the skin for an additional 5-10 minutes, depending on skin tolerance and/or sensitivity. Avoid the eye area. Rinse well and follow suggested post-mark home care reigimen. Use this product according the recommendations of your skin care professional. Skip the massage step with Grade 3 and 4 Acne.





Description

INDICATIONS AND USAGE: Formulated as a home treatment for acne-prone skin, this mask gently exfoliates the skin's surface with jojoba beads, allowing the follicular-oxidizing benefits of Benzoyl Peroxide to penetrate and take effect. Plant extracts and MSM are also included to increase healing time and assist in preventing future breakouts. DIRECTIONS: Apply to cleansed skin using fingertips. Massage gently in circular movements for 1-2 minutes and then allow the product to remain on the skin for an additional 5-10 minutes, depending on skin tolerance and/or sensitivity. Avoid the eye area. Rinse well and follow suggested post-mark home care reigimen. Use this product according the recommendations of your skin care professional. Skip the massage step with Grade 3 and 4 Acne.

Section 51727-6

INACTIVE INGREDIENTS:

Water (Aqua), Butylene Glycol, Jojoba Esters, Glycerin, Sorbitol, Dimethyl Sulfone, Silver, Polysorbate-20, Caprylyl Glycol, Salix alba (Willow) Bark Extract, Carbomer, Triethanolamine, Phenoxyethanol, Extracts of Malva Sylvestris (Mallow), Mentha piperita (Peppermint) Leaf, Primula Veris, Alchemilla vulgaris, Veronica Officinalis, Melissa Officinalis Leaf, Achillea Millefolium, Melia Azadiracta (Neem) Leaf Extract, PEG-60 Almond Glycerides-Nordihydroguaiaretic Acid-Oleanolic Acid, Sodium Benzoate, Disodium EDTA

Section 51945-4

DISTRIBUTOR:

Dermaquest, Inc

Hayward, CA

www.dermaquestinc.com



PRINCIPAL DISPLAY PANEL:









Section 55106-9

ACTIVE INGREDIENT:

Benzoyl Peroxide 2.5%


Structured Label Content

Indications and Usage (34067-9)

INDICATIONS AND USAGE:

Formulated as a home treatment for acne-prone skin, this mask gently exfoliates the skin's surface with jojoba beads, allowing the follicular-oxidizing benefits of Benzoyl Peroxide to penetrate and take effect. Plant extracts and MSM are also included to increase healing time and assist in preventing future breakouts.



DIRECTIONS:



Apply to cleansed skin using fingertips. Massage gently in circular movements for 1-2 minutes and then allow the product to remain on the skin for an additional 5-10 minutes, depending on skin tolerance and/or sensitivity. Avoid the eye area. Rinse well and follow suggested post-mark home care reigimen. Use this product according the recommendations of your skin care professional. Skip the massage step with Grade 3 and 4 Acne.





Section 51727-6 (51727-6)

INACTIVE INGREDIENTS:

Water (Aqua), Butylene Glycol, Jojoba Esters, Glycerin, Sorbitol, Dimethyl Sulfone, Silver, Polysorbate-20, Caprylyl Glycol, Salix alba (Willow) Bark Extract, Carbomer, Triethanolamine, Phenoxyethanol, Extracts of Malva Sylvestris (Mallow), Mentha piperita (Peppermint) Leaf, Primula Veris, Alchemilla vulgaris, Veronica Officinalis, Melissa Officinalis Leaf, Achillea Millefolium, Melia Azadiracta (Neem) Leaf Extract, PEG-60 Almond Glycerides-Nordihydroguaiaretic Acid-Oleanolic Acid, Sodium Benzoate, Disodium EDTA

Section 51945-4 (51945-4)

DISTRIBUTOR:

Dermaquest, Inc

Hayward, CA

www.dermaquestinc.com



PRINCIPAL DISPLAY PANEL:









Section 55106-9 (55106-9)

ACTIVE INGREDIENT:

Benzoyl Peroxide 2.5%


Advanced Ingredient Data


Raw Label Data

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