Label: CLARITY CLEAR SKIN SOLUTIONS ACNE SPOT TREATMENT- benzoyl peroxide cream
- NDC Code(s): 54473-402-01
- Packager: Melaleuca, Inc.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated May 24, 2024
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- INDICATIONS & USAGE
- Warnings
- DO NOT USE
-
WHEN USING
When using this product
- skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time. If this occurs, only one medication should be used unless otherwise directed by a doctor.
- avoid unnecessary sun exposure and use a sunscreen
- avoid contact with eyes, lips, and mouth
- avoid contact with hair and dyed fabrics, which may be bleached by this product
- skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in lower concentration.
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions
- cleanse and tone skin thoroughly before application
- cover the entire affected area with a thin layer 1-3 times daily
- because excessive drying of the skin may occur, start with one application daily, and then gradually increase to two or three times daily if needed or as directed by a doctor
- if bothersome dryness or peeling occurs, reduce daily application to once a day or every other day
- if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use and ask a doctor.
- Sensitivity Test for a New User: Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above.
Other Information Store at room temperature 68-77°. Protect from freezing.
-
INACTIVE INGREDIENT
Aqua (Water/Eau), Benzoyl Peroxide Gel, Glycerin, Panthenol, Ethyl Macadamiate, Cetyl Alcohol, Stearic Acid, Niacinamide, Polyglyceryl-3 Methyl Glucose Distearate, Glyceryl Stearate, PEG-100 Stearate, Cetearyl Alcohol, Steareth-21, Phenoxyethanol, Bisabolol, Polysorbate 60, Steareth-2, Xanthan Gum, Allantoin, Potassium Sorbate, Chlorella Vulgaris Extract.
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
CLARITY CLEAR SKIN SOLUTIONS ACNE SPOT TREATMENT
benzoyl peroxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54473-402 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 1.5 g in 15 mL Inactive Ingredients Ingredient Name Strength STEARETH-2 (UNII: V56DFE46J5) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) ALLANTOIN (UNII: 344S277G0Z) PEG-100 STEARATE (UNII: YD01N1999R) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CHLORELLA VULGARIS (UNII: RYQ4R60M02) CETYL ALCOHOL (UNII: 936JST6JCN) STEARETH-21 (UNII: 53J3F32P58) PANTHENOL (UNII: WV9CM0O67Z) STEARIC ACID (UNII: 4ELV7Z65AP) POLYSORBATE 60 (UNII: CAL22UVI4M) NIACINAMIDE (UNII: 25X51I8RD4) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYL MACADAMIATE (UNII: ANA2NCS6V1) WATER (UNII: 059QF0KO0R) POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6) LEVOMENOL (UNII: 24WE03BX2T) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54473-402-01 15 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product 01/01/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M006 01/01/2024 Labeler - Melaleuca, Inc. (139760102) Registrant - Melaleuca, Inc. (079711683) Establishment Name Address ID/FEI Business Operations Melaleuca, Inc. 079711683 manufacture(54473-402)