CLARITY CLEAR SKIN SOLUTIONS ACNE SPOT TREATMENT- benzoyl peroxide cream

Clarity Clear Skin Solutions by

Drug Labeling and Warnings

Clarity Clear Skin Solutions by is a Otc medication manufactured, distributed, or labeled by Melaleuca, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Benzoyl peroxide 10%

Purpose

Acne Treatment

INDICATIONS & USAGE

Uses for the treatment and management of acne

Warnings

For external use only.

DO NOT USE

Do not use if you

• have very sensitive skin
• are sensitive to benzoyl peroxide

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

Stop use and ask a doctor if excessive irritation of the skin develops

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away. Avoid contact with eyes. If contact occurs, flush thoroughly with water.

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 cream

Product 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)