NDC 63824-436 Clearasil Stubborn Acne Control 5in1 Exfoliating Wash

Salicylic Acid

NDC Product Information

Clearasil Stubborn Acne Control 5in1 Exfoliating Wash with NDC 63824-436 is a a human over the counter drug product labeled by Rb Health (us) Llc. The generic name of Clearasil Stubborn Acne Control 5in1 Exfoliating Wash is salicylic acid. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Rb Health (us) Llc

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

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.

Clearasil Stubborn Acne Control 5in1 Exfoliating Wash Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • SALICYLIC ACID 2 g/100mL

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)
  • PPG-15 STEARYL ETHER (UNII: 1II18XLS1L)
  • HYDRATED SILICA (UNII: Y6O7T4G8P9)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • CETYL BETAINE (UNII: E945X08YA9)
  • DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • ALCOHOL (UNII: 3K9958V90M)
  • STEARETH-21 (UNII: 53J3F32P58)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • DOCOSANOL (UNII: 9G1OE216XY)
  • STEARETH-2 (UNII: V56DFE46J5)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
  • HELICHRYSUM ITALICUM FLOWER (UNII: P62Y550X24)
  • METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
  • MICA (UNII: V8A1AW0880)
  • FERRIC FERROCYANIDE (UNII: TLE294X33A)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

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

Labeler Name: Rb Health (us) Llc
Labeler Code: 63824
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: 12-05-2017 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Clearasil Stubborn Acne Control 5in1 Exfoliating Wash Product Label Images

Clearasil Stubborn Acne Control 5in1 Exfoliating Wash 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

Other

Drug Facts

Active Ingredient

Salicylic acid 2%

Purpose

Acne medication

Use

For the treatment of acne

Warnings

For external use only

When Using This Product

  • Avoid contact with the eyes. If product gets into the eyes, rinse thoroughly with water.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.limit use to the face and neck

Otc - Stop Use

Stop use and ask a doctor if skin or eye irritation develops

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Wet facedispense product into hands, lather and massage gently onto face and neck, avoiding the delicate eye arearinse thoroughly with warm water one too 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

Other Information

  • Keep tightly closedstore in a cool, dry place

Inactive Ingredients

Water, PPG-15 Stearyl Ether, Hydrated Silica, Glycerin, Stearyl Alcohol, Cetyl Betaine, Distearyldimonium Chloride, Sodium Lauryl Sulfate, Cetyl Alcohol, Alcohol Denat, Steareth-21, Sodium Chloride, Behenyl Alcohol, Synthetic Wax, Steareth-2, Xanthan Gum, Fragrance, MEK, Disodium EDTA, Isopropyl Alcohol, BHT, Lavandula Stoechas Extract, Methylchloroisothiazolinone, Helichrysum Italicum Extract, Methylisothiazolinone, Cistus Monspeliensis Extract, Mica, Ferric Ferrocyanide, Titanium Dioxide, FD&C Blue No. 1

Questions?

1-866-25-CLEAR (1-866-252-5327).You may also report side effects to this phone number.

* Please review the disclaimer below.