NDC 51531-8968 Clear Proof Acne System The Go Set

Benzoyl Peroxide And Salicylic Acid

NDC Product Code 51531-8968

NDC 51531-8968-0

Package Description: 1 KIT in 1 CARTON * 26 mL in 1 BOTTLE * 28 g in 1 TUBE * 29 mL in 1 TUBE * 3 g in 1 TUBE

NDC Product Information

Clear Proof Acne System The Go Set with NDC 51531-8968 is a a human over the counter drug product labeled by Mary Kay Inc.. The generic name of Clear Proof Acne System The Go Set is benzoyl peroxide and salicylic acid. The product's dosage form is kit and is administered via form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 1489132, 1491648, 1493165, 1493511, 1493512, 251577, 308694 and 562600.

Dosage Form: Kit - A packaged collection of related material.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • 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)
  • 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)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM C14 OLEFIN SULFONATE (UNII: N816E2SOKI)
  • 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)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Mary Kay Inc.
Labeler Code: 51531
FDA Application Number: part333D What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 08-15-2013 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Information for Patients

Benzoyl Peroxide Topical

Benzoyl Peroxide Topical is pronounced as (ben' zoe il)

Why is benzoyl peroxide topical medication prescribed?
Benzoyl peroxide is used to treat mild to moderate acne....
[Read More]
Salicylic Acid Topical

Salicylic Acid Topical is pronounced as (sal'' i sil' ik as' id)
Why is salicylic acid topical medication prescribed?
Topical salicylic acid is used to help clear and prevent pimples and skin blemishes in people who have acne. Topical salicylic acid is also used to treat skin conditions ...
[Read More]

* Please review the disclaimer below.

Clear Proof Acne System The Go Set Product Label Images

Clear Proof Acne System The Go Set Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Clarifying Cleansing Gel 1 Oz. Net Wt. / 28 G

Drug Facts

Active Ingredient

Salicylic Acid (2% W/W)

Salicylic Acid (2% W/W)

Benzoyl Peroxide 5%

Purpose

Acne Medication

Acne Medication

Acne Medication

Uses

  • For the management of acnereduces the number of blackheads and acne pimpleshelps prevent new acne pimples

  • For the management of acnereduces the number of blackheads and acne pimpleshelps prevent new acne pimples

  • For the management of acnedries up acne pimpleshelps prevent new acne pimples

Warnings

For external use only

For external use only

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 contact with the eyes

  • 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 contact with the eyes

  • 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 sunscreenavoid contact with the eyes, lips, and mouthavoid contact with hair and dyed fabrics, which may be bleached by this productskin 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.

Stop Use And Ask A Doctor If

Irritation or sensitivity develops or increases

Irritation or sensitivity develops or increases

Irritation becomes severe

Keep Our Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Cleanse skin thoroughly before applying medicationcover the entire affected area with a thin layer then rinse thoroughly one to three times dailybecause 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 doctorif bothersome dryness or peeling occurs, reduce application to once a day or every other day

  • Cleanse the skin thoroughly before applying this productcover the entire affected area with a thin layer one to three times dailybecause 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 doctorif bothersome dryness or peeling occurs, reduce application to once a day or every other day

  • Cleanse the skin thoroughly before applying this productcover the entire affected area with a thin layer one to three times dailybecause 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 doctorif bothersome dryness or peeling occurs, reduce application to once a day or every other dayif going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

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

Alcohol denat., citric acid, diethylhexyl sodium sulfosuccinate, eucalyptus globulus leaf oil, menthol, propylene glycol, simethicone, water

Aesculus hippocastanum (horse chestnut) seed extract, butylene glycol, carbomer, cucumis sativus (cucumber) fruit extract, diethylhexyl sodium sulfosuccinate, disodium EDTA, echinacea purpurea extract, glycerin, poloxamer 182, propylene glycol, silica, sodium hydroxide, water

Blemish Control Toner .9 Fl. Oz. / 26 Ml

Drug Facts

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

If swallowed, get medical help or contact a Poison Control Center right away.

Acne Treatment Gel .1 Oz. Net Wt. / 3 G

Drug Facts

Do Not Use If You

  • Have very sensitive skinare sensitive to benzoyl peroxide

Other Information

  • Store at 59° F to 86° Fexpiration date on tube crimp

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

* Please review the disclaimer below.