CLENZIDERM M.D. SYSTEM ACNE THERAPEUTIC SYSTEM- salicylic acid and benzoyl peroxide kit
clenziderm m.d. system by
Drug Labeling and Warnings
clenziderm m.d. system by is a Otc medication manufactured, distributed, or labeled by OBAGI COSMECEUTICAL LLC, G.S.COSMECEUTICAL USA, INC., PURETEK CORPORATION. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- Daily Care Foaming Cleanser 4 fl. oz. (118 mL) AM+PM
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
- Warnings
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Directions
- Cleanse the entire affected area with a thin layer and rinse thoroughly one to three times daily.
- Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.
- If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
- Other information
- Inactive ingredients
- Questions or comments?
- Pore Therapy 5 fl. oz. (148 mL) AM+PM
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
- Warnings
-
Directions
- Cleanse the skin thoroughly before applying this product.
- Shake product well before use.
- Place a cotton ball or pad over the pump well and pump 2 to 3 times to saturate, then cover the entire affected area with a thin layer one to three times daily.
- Allow the product to air-dry completely; do not rinse off.
- Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.
- If bothersome dryness or peeling occurs, reduce application to once a day or every other day .
- Other information
- Inactive ingredients
- Questions or comments?
- Therapeutic Lotion 1.6 fl. oz. (47 mL) AM+PM
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
-
Warnings
For external use only
When using this product
- skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time
- avoid unnecessary sun exposure and use a sunscreen
- avoid contact with the 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 a lower concentration.
-
Directions
- Cleanse the skin thoroughly before applying this product.
- Cover the entire affected area with a thin layer one to three times daily.
- Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.
- If bothersome dryness or peeling occurs, reduce 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 of both products and ask a doctor.
- Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - Kit Carton
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INGREDIENTS AND APPEARANCE
CLENZIDERM M.D. SYSTEM ACNE THERAPEUTIC SYSTEM
salicylic acid and benzoyl peroxide kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 62032-613 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 62032-613-01 1 in 1 CARTON; Type 0: Not a Combination Product 01/01/2012 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE, PLASTIC 118 mL Part 2 1 BOTTLE, PLASTIC 148 mL Part 3 1 BOTTLE, PLASTIC 47 mL Part 1 of 3 CLENZIDERM DAILY CARE FOAMING CLEANSER ACNE TREATMENT
salicylic acid liquidProduct Information Item Code (Source) NDC: 62032-610 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 20 mg in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0) SODIUM LAURYL SULFATE (UNII: 368GB5141J) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT) EDETATE DISODIUM (UNII: 7FLD91C86K) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I) EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728) WATER (UNII: 059QF0KO0R) DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) CHAMOMILE (UNII: FGL3685T2X) Glycerin (UNII: PDC6A3C0OX) Product Characteristics Color PURPLE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 62032-610-04 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part333D 02/01/2007 Part 2 of 3 CLENZIDERM PORE THERAPY ACNE TREATMENT
salicylic acid liquidProduct Information Item Code (Source) NDC: 62032-612 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 20 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) BENZYL ALCOHOL (UNII: LKG8494WBH) 3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL (UNII: KD6TZ2QICH) GLYCERIN (UNII: PDC6A3C0OX) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I) EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728) WATER (UNII: 059QF0KO0R) CHAMOMILE (UNII: FGL3685T2X) Product Characteristics Color PURPLE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 62032-612-04 148 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part333D 02/01/2007 Part 3 of 3 CLENZIDERM THERAPEUTIC
benzoyl peroxide lotionProduct Information Item Code (Source) NDC: 62032-611 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength BENZYL BENZOATE (UNII: N863NB338G) DICAPRYLYL ETHER (UNII: 77JZM5516Z) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SQUALANE (UNII: GW89575KF9) POLYSORBATE 60 (UNII: CAL22UVI4M) DIMETHYL ISOSORBIDE (UNII: SA6A6V432S) PHENOXYETHANOL (UNII: HIE492ZZ3T) EDETATE DISODIUM (UNII: 7FLD91C86K) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) WATER (UNII: 059QF0KO0R) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 62032-611-01 47 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part333D 07/01/2007 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part333D 01/01/2012 Labeler - OBAGI COSMECEUTICAL LLC (790553353) Establishment Name Address ID/FEI Business Operations G.S.COSMECEUTICAL USA, INC. 017014734 MANUFACTURE(62032-613) Establishment Name Address ID/FEI Business Operations PURETEK CORPORATION 785961046 MANUFACTURE(62032-613) , LABEL(62032-613) , PACK(62032-613)
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