Label: ACNE TX MASK- benzoyl peroxide cream
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated August 10, 2010
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INDICATIONS & USAGE
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.
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
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
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
ACNE TX MASK
benzoyl peroxide cream
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62742-4050 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 25 mg in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62742-4050-1 118.3 mL in 1 TUBE 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)