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Name:Acne Tx Mask
Manufacturer:Allure Labs, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

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.

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Drug Facts

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






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
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
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.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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