Acne Wipeout All Day Breakout Control
Drug Facts
Acne Wipeout Clinical Acne System
FDA Label NDC 50544-150
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by University Medical Pharmaceuticals Corp. for the product Acne Wipeout Clinical Acne System (NDC 50544-150). 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 acne wipeout all day breakout control, active ingredient, purpose, use, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Benzoyl Peroxide 5% w/v
Benzoyl Peroxide 2.5% w/v
Purpose
Acne treatment
Acne treatment
Use
• For the treatment of acne
• For the treatment of acne
Warnings
For external use only.
Do not use • If you are sensitive to Benzoyl Peroxide or have very sensitive skin. This product may cause irritation. Ask a doctor or pharmacist before use • If you are using other topical acne drugs at the same time or right after use of this product. This may increase dryness, redness or irritation of the skin. If this occurs, only one medication should be used unless a doctor directs otherwise.
When using this product • Avoid contact with eyes. If contact occurs, flush thoroughly with water. Keep away from lips and mouth. • Avoid unnecessary sun exposure and use a sunscreen. • Avoid product contact with hair and dyed fabrics, including towels, carpets and clothing which may be bleached by this product.
Stop use and ask a doctor if
• if excessive irritation occurs.
For external use only.
Do not use • If you are sensitive to Benzoyl Peroxide or have very sensitive skin. This product may cause irritation. Ask a doctor or pharmacist before use • If you are using other topical acne drugs at the same time or right after use of this product. This may increase dryness, redness or irritation of the skin. If this occurs, only one medication should be used unless a doctor directs otherwise.
When using this product • Avoid contact with eyes. If contact occurs, flush thoroughly with water. Keep away from lips and mouth. • Avoid unnecessary sun exposure and use a sunscreen. • Avoid product contact with hair and dyed fabrics, including towels, carpets and clothing which may be bleached by this product.
Stop use and ask a doctor if
• excessive irritation occurs.
For external use only.
Avoid contact with eyes. If contact occurs, flush thoroughly with water. Keep away from lips and mouth.
Sunburn Alert
Use a sunscreen, wear protective clothing and limit sun exposure while using this product.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center immediately.
Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center immediately.
Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center immediately.
Directions
Adults and children 12 years of age and older:
Use every morning after cleansing with Acne Wipeout™ Clear Pore Oil-Free Cleanser. Apply a dime-size amount to clean skin, avoiding the eye area. Do not rinse. If bothersome dryness or irritation occurs, reduce frequency of use.
Adults and children 12 years of age and older:
Use every morning and evening. Apply to damp skin and gently massage, avoiding the eye area. Rinse well. If bothersome dryness or irritation occurs, reduce frequency of use.
Use only at night. Apply to face after cleansing with Acne Wipeout™ Clear Pore Oil-Free Cleanser. Do not rinse. Limit sun exposure, and use sunscreen when going outdoors. Formulated to minimize irritation. If any irritation occurs, reduce frequency of use.
Other Information
• store at room temperature (68° to 77° F)
• Protect from freezing
- store at room temperature (68° to 77° F)
- Protect from freezing
Inactive Ingredients
Water (Aqua), Sodium C14-16 Olefin Sulfonate, PEG-8, Disodium Laureth Sulfosuccinate, Polyacrylate-1 Crosspolymer, Cocamidopropyl Betaine, Allyl Methacrylates Crosspolymer, Butylene Glycol, Glycerin, DMDM Hydantoin, Tocopheryl Acetate (Vitamin E Acetate), Glycyrrhiza Glabra (Licorice) Root Extract, Calendula Officinalis Flower Extract, Hamamelis Virginiana (Witch Hazel) Extract, Citric Acid, Tetrasodium EDTA, Sodium Hydroxide, Fragrance, Sodium Benzotriazolyl Butylphenol Sulfonate, Benzoic Acid.
Carbomer, Ethylhexylglycerin, Jojoba Esters, Phenoxyethanol, Sodium Hydroxide, Water, Silica, Sodium Dioctyl Sulfosuccinate, Xanthan Gum, 1,3 Propanediol, Dimethicone, PEG-40 Stearate.
Acne Wipeout Clear Pore Oil-Free Cleanser
Drug Facts
Acne Wipeout Time-Released Retinol Plus Night Cream
Ingredients
Caprylic/Capric Triglyeride, Glycerin, Silica, Cetearyl Alcohol, Butyrospermum Parkii (Shea) Butter, Glyceryl Stearate, Retinol, Ceramide-3, Chlorhexidine Gluconate, polysorbate 20, Laureth-23, Cetyl Palmitate, Tridecth-6 Phosphate, Pentylene Glycol, Dimethicone, Ceteareth-20, Carbomer, Sodium Hydroxide, PPG-12 SMDI Copolymer, PEG-100 Stearate, Phenoxyethanol, Disodium EDTA, Ethylhexylglycerin
Packaging
Acne3 (50544150 3)
Acne4 (50544150 4)
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