Label: CLEAR PROOF ACNE SYSTEM THE GO SET- benzoyl peroxide and salicylic acid kit
- NDC Code(s): 51531-8968-0
- Packager: Mary Kay Inc.
- 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 September 23, 2022
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- Official Label (Printer Friendly)
- Clarifying Cleansing Gel 1 OZ. NET WT. / 28 g
- Active ingredient
- Uses
- Warnings
-
Directions
- cleanse skin thoroughly before applying medication
- cover the entire affected area with a thin layer then 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
-
Inactive ingredients
arctium lappa root extract, butylene glycol, citric acid, cocamidopropyl betaine, cystoseira amentacea/caespitosa branchycarpa extract, disodium EDTA, DMDM hydantoin, epilobium angustifolium flower/leaf/stem extract, ethylparaben, glycerin, methylparben, phenoxyethanol, propylene glycol, propylparaben, sodium C14-16 olefin sulfonate, sodium chloride, triethanolamine, water
- Blemish Control Toner .9 FL. OZ. / 26 mL
- Active ingredient
- Uses
- Warnings
-
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
- Inactive ingredients
- Acne Treatment Gel .1 OZ. NET WT. / 3 g
- Active ingredient
- 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
- Oil-Free Moisturizer for Acne-Prone Skin 1 FL. OZ. / 29 mL
-
INGREDIENTS:
Water/Eau, Glycerin, Cetearyl Ethylhexanoate, Butylene Glycol, Caprylic/Capric Triglyceride, Glyceryl Stearate, Dimethicone, Isostearyl Alcohol, Stearic Acid, Betaine, Niacinamide, PEG-100 Stearate, Cetyl Alcohol, Cucurbita Pepo (Pumpkin) Fruit Extract, Silybum Marianum Fruit Extract, Tocopheryl Acetate, Lactobacillus/Ganoderma Lucidum (Reishi) Extract/Lentinus Edodes (Truncated), PEG-4 Laurate, Triethanolamine, Xanthan Gum, Carbomer, Disodium EDTA, Iodopropynyl Butylcarbamate, Phenoxyethanol, Diazolidinyl Urea, Sodium Benzoate
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Principal Display Panel - The Go Set carton
Mary Kay
clear proof
acne system
the go set
clarifying cleansing gel salicylic acid acne medication 1 OZ. NET WT. / 28 g
blemish control toner salicylic acid acne medication liquid .9 FL. OZ. / 26 mL
acne treatment gel benzoyl peroxide acne medication .1 OZ. NET WT. / 3 g
oil-free moisturizer for acne-prone skin 1 FL. OZ. / 29 mL
-
INGREDIENTS AND APPEARANCE
CLEAR PROOF ACNE SYSTEM THE GO SET
benzoyl peroxide and salicylic acid kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51531-8968 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51531-8968-0 1 in 1 CARTON 08/15/2013 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 TUBE 3 g Part 2 1 BOTTLE 26 mL Part 3 1 TUBE 28 g Part 4 1 TUBE 29 mL Part 1 of 4 CLEAR PROOF ACNE TREATMENT ACNE MEDICATION
benzoyl peroxide gelProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 5 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POLOXAMER 182 (UNII: JX0HIX6OAG) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) SODIUM HYDROXIDE (UNII: 55X04QC32I) DOCUSATE SODIUM (UNII: F05Q2T2JA0) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ECHINACEA PURPUREA (UNII: QI7G114Y98) CUCUMBER (UNII: YY7C30VXJT) HORSE CHESTNUT (UNII: 3C18L6RJAZ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 3 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M006 08/15/2013 Part 2 of 4 CLEAR PROOF BLEMISH CONTROL TONER ACNE MEDICATION
salicylic acid liquidProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 2 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) DENATONIUM BENZOATE (UNII: 4YK5Z54AT2) TERT-BUTYL ALCOHOL (UNII: MD83SFE959) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) DOCUSATE SODIUM (UNII: F05Q2T2JA0) EUCALYPTUS OIL (UNII: 2R04ONI662) MENTHOL (UNII: L7T10EIP3A) DIMETHICONE (UNII: 92RU3N3Y1O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 26 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M006 08/15/2013 Part 3 of 4 CLEAR PROOF CLARIFYING CLEANSING GEL ACNE MEDICATION
salicylic acid gelProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 2 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) SODIUM CHLORIDE (UNII: 451W47IQ8X) TROLAMINE (UNII: 9O3K93S3TK) EDETATE DISODIUM (UNII: 7FLD91C86K) PHENOXYETHANOL (UNII: HIE492ZZ3T) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) METHYLPARABEN (UNII: A2I8C7HI9T) ETHYLPARABEN (UNII: 14255EXE39) DMDM HYDANTOIN (UNII: BYR0546TOW) ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3) PROPYLPARABEN (UNII: Z8IX2SC1OH) GLYCERIN (UNII: PDC6A3C0OX) EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP (UNII: 08H094218D) SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 28 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M006 08/15/2013 Part 4 of 4 CLEAR PROOF OIL-FREE MOISTURIZER FOR ACNE-PRONE SKIN
other skin care preparationsProduct Information Other Ingredients Ingredient Kind Ingredient Name Quantity INGR WATER (UNII: 059QF0KO0R) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25) INGR BUTYLENE GLYCOL (UNII: 3XUS85K0RA) INGR MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) INGR GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) INGR DIMETHICONE (UNII: 92RU3N3Y1O) INGR BETAINE (UNII: 3SCV180C9W) INGR STEARIC ACID (UNII: 4ELV7Z65AP) INGR ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y) INGR PEG-100 STEARATE (UNII: YD01N1999R) INGR NIACINAMIDE (UNII: 25X51I8RD4) INGR DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) INGR CETYL ALCOHOL (UNII: 936JST6JCN) INGR CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) INGR EDETATE DISODIUM (UNII: 7FLD91C86K) INGR .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) INGR PEG-4 LAURATE (UNII: AYF4VM3N1Z) INGR TROLAMINE (UNII: 9O3K93S3TK) INGR XANTHAN GUM (UNII: TTV12P4NEE) INGR PUMPKIN (UNII: SYW0QUB89Y) INGR MILK THISTLE (UNII: U946SH95EE) INGR IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) INGR PHENOXYETHANOL (UNII: HIE492ZZ3T) INGR SODIUM BENZOATE (UNII: OJ245FE5EU) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 29 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 08/15/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M006 08/15/2013 Labeler - Mary Kay Inc. (049994452) Establishment Name Address ID/FEI Business Operations Port Jervis Laboratories Inc. 001535103 manufacture(51531-8968) Establishment Name Address ID/FEI Business Operations Mary Kay Inc. 103978839 manufacture(51531-8968) Establishment Name Address ID/FEI Business Operations Komplete Group Inc. 858820962 pack(51531-8968)