OTC Medication Information: Acne TX Mask

ACNE TX MASK — benzoyl peroxide cream
Allure Labs, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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.

ACTIVE INGREDIENT:

Benzoyl Peroxide 2.5%

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

DISTRIBUTOR:

Dermaquest, Inc

Hayward, CA

www.dermaquestinc.com

PRINCIPAL DISPLAY PANEL:

Principal Display Panel: Acne TX Mask
(click image for full-size original)


ACNE TX MASK
benzoyl peroxide cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:62742-4050
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 25 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62742-4050-1 118.3 mL in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333 01/01/2010
Labeler — Allure Labs, Inc. (926831603)

Revised: 08/2010 Allure Labs, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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