Label: CLENZIDERM M.D. SYSTEM ACNE THERAPEUTIC SYSTEM- salicylic acid and benzoyl peroxide kit
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NDC Code(s):
62032-610-11,
62032-611-01,
62032-612-04,
62032-613-01, view more62032-613-09, 62032-613-15
- Packager: OBAGI COSMECEUTICAL LLC
- 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.
Drug Label Information
Updated March 8, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- 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
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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
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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 12/31/2021 2 NDC:62032-613-09 1 in 1 CARTON; Type 0: Not a Combination Product 11/01/2021 3 NDC:62032-613-15 1 in 1 CARTON 11/01/2012 12/31/2022 3 1 in 1 BAG; Type 0: Not a Combination Product 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) BUTYL AVOCADATE (UNII: Q86RQ0D402) DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) CHAMOMILE (UNII: FGL3685T2X) Glycerin (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) Product Characteristics Color PURPLE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62032-610-11 118 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 Denison Pharmaceuticals, LLC 001207208 MANUFACTURE(62032-613)