Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 45a93c47-552f-4660-a37c-7a8cceac2d8e
Route
TOPICAL
Published
Effective Date 2015-05-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (100 mg)
Inactive Ingredients
Hexylene Glycol Phenoxyethanol Caprylyl Glycol Propylene Glycol Glycerin Alchemilla Xanthochlora Flowering Top Veronica Officinalis Flowering Top Achillea Millefolium Azadirachta Indica Leaf Peg-60 Almond Glycerides Masoprocol Tea Tree Oil Manuka Oil Annickia Chlorantha Bark Dimethyl Sulfone Malva Sylvestris Flowering Top Melissa Officinalis Leaf Butylene Glycol Oleanolic Acid Water Sorbitol Peg-8/smdi Copolymer Ethylhexylglycerin Carbomer Homopolymer, Unspecified Type Trolamine Silver Salix Alba Bark Maltodextrin Mentha Piperita Leaf Primula Veris Syringa Vulgaris Whole Edetate Disodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-05-05
Description

Active Ingredient - Benzoyl Peroxide 10%

Medication Information

Warnings and Precautions

Warnings:

  • For external use only
Indications and Usage

Uses:

  • For the treatment of acne
Dosage and Administration

Directions:

  • Apply product to affected area using applicator wand. Avoid eye area.
Description

Active Ingredient - Benzoyl Peroxide 10%

Section 50565-1

Keep out of reach of children:

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

Section 50566-9

Stop use and ask a doctor:

  • If severe skin irritation occurs.
  • Using other topical medication at the same time
Section 50567-7

When using this product:

  • Avoid contact with the eyes, lips, and mouth
  • Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.
  • If sensitive to the sun or when increased sun exposure is expected use a sunscreen.
Section 51727-6

Inactive Ingredients:

Water ( Aqua),Propylene Glycol, Glycerin, Sorbitol, Dimethyl Sulfone, PEG-8/SMDI Copolymer, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Carbomer, Triethanolamine, Collidal Silver, Salix Alba (Willow) Bark Extract, Malva Sylvestns (Mallow) Extract, Mentha Pipenta (Peppermint) Leaf Extract, Primula Veris Extract, Alchemilla Vulgaris Extract, Veronica Officinalis Extract, Melissa Officinalis Leaf Extract, Achillea Millefolium Extract, Melia Azadirachta Leaf Extract, Butylene Glycol, PEG-60 Almond Glycerides, Nordihydroguaiaretic Acid, Oleanolic Acid, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Leptospermum Scoparium Branch/ Leaf Oil, Enantia Chlorantha Bark Extract, Maltodextrin, Syringa Vulgaris (Lilac) Leaf Cell Culture Extract, Disodium EDTA

Section 51945-4

Manufactured for DermaQuest®, Inc.

Hayward, CA 94544

1272 GK, NL Made in USA

dermaquestinc.com

Section 55105-1

Purpose: Acne Treatment

Section 55106-9

Active Ingredient - Benzoyl Peroxide 10%

Structured Label Content

Indications and Usage (34067-9)

Uses:

  • For the treatment of acne
Dosage and Administration (34068-7)

Directions:

  • Apply product to affected area using applicator wand. Avoid eye area.
Warnings and Precautions (34071-1)

Warnings:

  • For external use only
Section 50565-1 (50565-1)

Keep out of reach of children:

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

Section 50566-9 (50566-9)

Stop use and ask a doctor:

  • If severe skin irritation occurs.
  • Using other topical medication at the same time
Section 50567-7 (50567-7)

When using this product:

  • Avoid contact with the eyes, lips, and mouth
  • Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.
  • If sensitive to the sun or when increased sun exposure is expected use a sunscreen.
Section 51727-6 (51727-6)

Inactive Ingredients:

Water ( Aqua),Propylene Glycol, Glycerin, Sorbitol, Dimethyl Sulfone, PEG-8/SMDI Copolymer, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Carbomer, Triethanolamine, Collidal Silver, Salix Alba (Willow) Bark Extract, Malva Sylvestns (Mallow) Extract, Mentha Pipenta (Peppermint) Leaf Extract, Primula Veris Extract, Alchemilla Vulgaris Extract, Veronica Officinalis Extract, Melissa Officinalis Leaf Extract, Achillea Millefolium Extract, Melia Azadirachta Leaf Extract, Butylene Glycol, PEG-60 Almond Glycerides, Nordihydroguaiaretic Acid, Oleanolic Acid, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Leptospermum Scoparium Branch/ Leaf Oil, Enantia Chlorantha Bark Extract, Maltodextrin, Syringa Vulgaris (Lilac) Leaf Cell Culture Extract, Disodium EDTA

Section 51945-4 (51945-4)

Manufactured for DermaQuest®, Inc.

Hayward, CA 94544

1272 GK, NL Made in USA

dermaquestinc.com

Section 55105-1 (55105-1)

Purpose: Acne Treatment

Section 55106-9 (55106-9)

Active Ingredient - Benzoyl Peroxide 10%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:38.465391 · Updated: 2026-03-14T23:05:32.543899