Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 69993325-d342-4b00-a387-762a83ace495
Route
TOPICAL
Published
Effective Date 2017-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (25 mg)
Inactive Ingredients
Water Sorbitol Cetyl Alcohol Stearyl Alcohol Propylene Glycol Glycerin Ammonium Lauryl Sulfate Phenoxyethanol Caprylyl Glycol Ethylhexylglycerin Hexylene Glycol Dimethyl Sulfone Ppg-12/smdi Copolymer Edetate Disodium Azadirachta Indica Leaf Silver Tea Tree Oil Salix Alba Bark Malva Sylvestris Flowering Top Mentha Piperita Leaf Primula Veris Alchemilla Xanthochlora Flowering Top Veronica Officinalis Flowering Top Butylene Glycol Peg-60 Almond Glycerides Carbomer Copolymer Type B (allyl Pentaerythritol Crosslinked) Nordihydroguaiaretic Acid, (+/-)- Oleanolic Acid Leptospermum Scoparium Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2017-11-28

Description

Active Ingredient: Benzoyl Peroxide - 2.5%


Medication Information

Warnings and Precautions

Warnings:

For external use only.

Indications and Usage

Uses:

For the treatment and management of mild acne.

Dosage and Administration

Directions:

  • Emulsify cleanser with lukewarm water and gently massage onto the skin.
  • Rinse well and pat dry.
  • Not recommended for those with nut allergies.

Description

Active Ingredient: Benzoyl Peroxide - 2.5%

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 severe skin irritation occurs.

Section 50567-7

When using this product:

  • Avoid contact with eyes, lips and mouth.
  • Avoid contact with hair and dyed fabric, which may be bleached by this product.

Section 50570-1

Do not use if you:

  • Have any sensitive skin.
  • Are sensitive to benzoyl peroxide.

Section 51727-6

Other Ingredients: Water (Aqua), Sorbitol, Cetyl Alcohol, Stearyl Alcohol, Propylene Glycol, Glycerin, Ammonium Lauryl Sulfate, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Dimethyl Sulfone, PPG-12/SMDI Copolymer, Disodium EDTA, Melia Azadirechta Leaf Extract, Silver, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Salix Alba (Willow) Bark Extract, Malva Sylvestris (Mallow) Extract, Mentha Piperita (Peppermint) Leaf Extract, Achillea Millefoluium Extract, Butylene Glycol, PEG-60 Almond Glycerides, Carbomer, Nordihydroguaiaretic Acid, Oleanolic Acid, Leptospermum Scoparium Branch/Leaf Oil.

Section 51945-4

Manufactured for DermaQuest, Inc.

Hayward, CA 94544

1272 GK, NL Made in USA

dermaquestinc.com

Section 55105-1

Purpose: Anti-acne

Section 55106-9

Active Ingredient: Benzoyl Peroxide - 2.5%


Structured Label Content

Indications and Usage (34067-9)

Uses:

For the treatment and management of mild acne.

Dosage and Administration (34068-7)

Directions:

  • Emulsify cleanser with lukewarm water and gently massage onto the skin.
  • Rinse well and pat dry.
  • Not recommended for those with nut allergies.

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 Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor - if severe skin irritation occurs.

Section 50567-7 (50567-7)

When using this product:

  • Avoid contact with eyes, lips and mouth.
  • Avoid contact with hair and dyed fabric, which may be bleached by this product.

Section 50570-1 (50570-1)

Do not use if you:

  • Have any sensitive skin.
  • Are sensitive to benzoyl peroxide.

Section 51727-6 (51727-6)

Other Ingredients: Water (Aqua), Sorbitol, Cetyl Alcohol, Stearyl Alcohol, Propylene Glycol, Glycerin, Ammonium Lauryl Sulfate, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Dimethyl Sulfone, PPG-12/SMDI Copolymer, Disodium EDTA, Melia Azadirechta Leaf Extract, Silver, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Salix Alba (Willow) Bark Extract, Malva Sylvestris (Mallow) Extract, Mentha Piperita (Peppermint) Leaf Extract, Achillea Millefoluium Extract, Butylene Glycol, PEG-60 Almond Glycerides, Carbomer, Nordihydroguaiaretic Acid, Oleanolic Acid, Leptospermum Scoparium Branch/Leaf Oil.

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: Anti-acne

Section 55106-9 (55106-9)

Active Ingredient: Benzoyl Peroxide - 2.5%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)