Dermaclear Spot Treatment Cream
FDA Label NDC 62742-4075

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Allure Labs Inc for the product Dermaclear Spot Treatment (NDC 62742-4075). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

Active Ingredient - Benzoyl Peroxide 10%

Otc - Purpose

Purpose: Acne Treatment

Indications & Usage

Uses:

  • For the treatment of acne

Warnings

Warnings:

  • For external use only

Otc - When Using

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.

Otc - Stop Use

Stop use and ask a doctor:

  • If severe skin irritation occurs.
  • Using other topical medication at the same time

Otc - Keep Out Of Reach Of Children

Keep out of reach of children:

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

Dosage & Administration

Directions

  • Apply a small portion over the affected area with finger tips and gently massage onto the skin.
  • Reapply as needed

Inactive Ingredient

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

Package Label.Principal Display Panel

Manufactured for

DermaQuest iNC,.

Hayward, CA  94544 1272 GK, NL

Made in USA

dermaquestinc.com

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