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Dermaclear spot treatment - Medication Information

Product NDC Code 62742-4075
Drug Name

Dermaclear spot treatment

Type Brand
Active Ingredients
Benzoyl peroxide 100 mg/g
Route TOPICAL
Dosage Form CREAM
RxCUI drug identifier 106315
Application Number part333D
Labeler Name Allure Labs Inc
Packages
Package NDC Code Description
62742-4075-4 1 bottle, with applicator in 1 carton (62742-4075-4) / 4.8 g in 1 bottle, with applicator (62742-4075-3)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient - Benzoyl Peroxide 10%

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Directions: Apply product to affected area using applicator wand. Avoid eye area.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
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

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses: For the treatment of acne

Purpose

Information about the drug product’s indications for use.
Purpose: Acne Treatment

Spl product data elements

Usually a list of ingredients in a drug product.
Dermaclear Spot Treatment Benzoyl Peroxide HEXYLENE GLYCOL BENZOYL PEROXIDE BENZOYL PEROXIDE PHENOXYETHANOL CAPRYLYL GLYCOL PROPYLENE GLYCOL GLYCERIN AZADIRACHTA INDICA LEAF ALCHEMILLA XANTHOCHLORA FLOWERING TOP VERONICA OFFICINALIS FLOWERING TOP ACHILLEA MILLEFOLIUM PEG-60 ALMOND GLYCERIDES MASOPROCOL TEA TREE OIL MANUKA OIL OLEANOLIC ACID ANNICKIA CHLORANTHA BARK DIMETHYL SULFONE MALVA SYLVESTRIS FLOWERING TOP MELISSA OFFICINALIS LEAF BUTYLENE GLYCOL ETHYLHEXYLGLYCERIN WATER SORBITOL PEG-8/SMDI COPOLYMER SALIX ALBA BARK CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE TROLAMINE SILVER MALTODEXTRIN EDETATE DISODIUM MENTHA PIPERITA LEAF PRIMULA VERIS SYRINGA VULGARIS WHOLE

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Manufactured for DermaQuest®, Inc. Hayward, CA 94544 1272 GK, NL Made in USA dermaquestinc.com IMGDERMST

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children: If swallowed, get medical help or contact a Poison Control Centre right away.

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop use and ask a doctor: If severe skin irritation occurs. Using other topical medication at the same time

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
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.

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings: For external use only

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API