NDC 71020-019 Just4u Oil Free Acne Wash

Salicylic Acid

NDC Product Code 71020-019

NDC 71020-019-23

Package Description: 236 mL in 1 BOTTLE

NDC Product Information

Just4u Oil Free Acne Wash with NDC 71020-019 is a a human over the counter drug product labeled by Sante Manufacturing Inc. The generic name of Just4u Oil Free Acne Wash is salicylic acid. The product's dosage form is soap and is administered via topical form.

Labeler Name: Sante Manufacturing Inc

Dosage Form: Soap - Any compound of one or more fatty acids, or their equivalents, with an alkali; soap is detergent and is much employed in liniments, enemas, and in making pills. It is also a mild aperient, antacid and antiseptic.

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.

Just4u Oil Free Acne 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.

  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
  • ALOE (UNII: V5VD430YW9)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • FD&C RED NO. 4 (UNII: X3W0AM1JLX)
  • SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • BASIC YELLOW 5 (UNII: 07BP340B4T)
  • EDETATE SODIUM (UNII: MP1J8420LU)
  • SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)

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: Sante Manufacturing Inc
Labeler Code: 71020
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: 03-16-2021 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.

Just4u Oil Free Acne Wash Product Label Images

Just4u Oil Free Acne 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

Otc - Active Ingredient

Active Ingredient PurposeSalicylic Acid - 2.0% w/w...........Acne Treatment

Purpose

Acne Treatment

Use:

For the treatment of acne.

Warnings

WarningsFor external use onlyWhen 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 eyes. If contact occurs, flush thoroughly with water,

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, contact physician or poison control center immediately.

Dosage & Administration

DirectionsCleanse twice a dayWet face, apply to hands, add water and work into a latherMassage face gentlyRinse thoroughly

Other Safety Information

Store at room temperature.

Questions

Made in Canada, Sante Manufacturing Inc.

Other Ingredients:

Water, Cocamidopropyl betaine, sodium C14-16 Olefin Sulfonate, sodium laureth sulfate, propylene glycol, tetrasodium EDTA, Fragrance, Aloe, benzalkonium chloride, yellow 5, red 40, red 4.

* Please review the disclaimer below.