NDC 74553-007 Okay Blemish Control Apricot Scrub

Salicylic Acid

NDC Product Code 74553-007

NDC CODE: 74553-007

Proprietary Name: Okay Blemish Control Apricot Scrub What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Salicylic Acid What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used on the skin to treat common skin and foot (plantar) warts. Salicylic acid helps cause the wart to gradually peel off. This medication is also used to help remove corns and calluses. This product should not be used on the face or on moles, birthmarks, warts with hair growing from them, or genital/anal warts. Salicylic acid is a keratolytic. It belongs to the same class of drugs as aspirin (salicylates). It works by increasing the amount of moisture in the skin and dissolving the substance that causes the skin cells to stick together. This makes it easier to shed the skin cells. Warts are caused by a virus. Salicylic acid does not affect the virus.

NDC Code Structure

  • 74553 - Xtreme Tools International, Inc
    • 74553-007 - Okay Blemish Control Apricot Scrub

NDC 74553-007-01

Package Description: 170 g in 1 TUBE

NDC Product Information

Okay Blemish Control Apricot Scrub with NDC 74553-007 is a a human over the counter drug product labeled by Xtreme Tools International, Inc. The generic name of Okay Blemish Control Apricot Scrub is salicylic acid. The product's dosage form is cream and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 562600.

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Okay Blemish Control Apricot Scrub 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.


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)
  • GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • JUGLANS REGIA SHELL (UNII: PJ10MT7VKA)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • HYDROLYZED WHEAT PROTEIN (ENZYMATIC; 3000 MW) (UNII: J2S07SB0YL)
  • APRICOT (UNII: 269CJD5GZ9)
  • SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
  • ACRYLAMIDE (UNII: 20R035KLCI)
  • TRIDECETH-6 (UNII: 3T5PCR2H0C)
  • CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • METHYLPROPANEDIOL (UNII: N8F53B3R4R)

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: Xtreme Tools International, Inc
Labeler Code: 74553
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: 04-21-2021 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: 12-31-2022 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.

Okay Blemish Control Apricot Scrub Product Label Images

Okay Blemish Control Apricot Scrub 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

Active Ingredient

Salicylic Acid……………….2%

Purpose

Acne Treatment

Use

For the treatment of acne

Warnings

For External use only

When Using This Product

Skin irritation and dryness may occur if using in conjunction with another acne medication.Stop using if irritation occurs, or only use one acne medication at a time.

Directions

Moisten skin with water and apply over face using fingertips. Rinse with warm water. For best results use 3-4 times a week. Avoid direct contact with eyes. If contact occurs rinse thoroughly with water.

Inactive Ingredients

Deionized water, Glyceryl Stearate, Propylene Glycol, Cetearyl Alcohol, Cocamidopropyl Betaine, Sodium Lauroyl lactylate, Glycerin, PEG-100 Stearate, Glyceryl Stearate, Juglans Regia (Walnut) Shell Powder, Cetyl Alcohol, Ceteareth-20, Polysorbate 60, Titanium Dioxide UF, Hydrolyzed Wheat Protein, Prunus Armeniaca (Apricot) Fruit Extract, Sodium Polyacrylate, Acrylamide Copolymer, Trideceth-6, Caprylhydroxamic Acid, Phenoxyethanol, Methylpropanediol, Fragrance

Package Label

170 g in Tube  (NDC 74553-007-01)

* Please review the disclaimer below.