NDC 57934-5012 Every Man Jack Charcoal Face Scrub

Salicylic Acid

NDC Product Code 57934-5012

NDC 57934-5012-4

Package Description: 125 mL in 1 TUBE

NDC Product Information

Every Man Jack Charcoal Face Scrub with NDC 57934-5012 is a a human over the counter drug product labeled by Every Man Jack. The generic name of Every Man Jack Charcoal Face Scrub is salicylic acid. The product's dosage form is cream and is administered via topical form.

Labeler Name: Every Man Jack

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.

Every Man Jack Charcoal Face 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.

  • 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)
  • CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
  • SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • HYDROGENATED JOJOBA OIL (UNII: 7F674YQ5SO)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • PISTACIA LENTISCUS RESIN (UNII: 7446H202QW)

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: Every Man Jack
Labeler Code: 57934
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: 06-16-2019 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: 12-31-2020 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.

Every Man Jack Charcoal Face Scrub Product Label Images

Every Man Jack Charcoal Face 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 MANAGEMENT OF ACNE

Warnings

FOR EXTERNAL USE ONLY.ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE USING OTHER TOPICAL ACNE MEDICATIONS AT THE SAME TIME OR IMMEDIATELY FOLLOWING THE USE OF THIS PRODUCT. THIS MAY INCREASE DRYNESS OR IRRITATION OF THE SKIN. IF THIS OCCURS, ONLY ONE MEDICATION SHOULD BE USED UNLESS DIRECTED BY A DOCTOR.WHEN USING THIS PRODUCT: AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER.

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

CLEANSE MORNING AND NIGHT. WET FACE. APPLY SCRUB INTO HANDS, LATHER WITH WATER. MASSAGE FACE GENTLY. RINSE THOROUGHLY. DRY WITH CLEAN TOWEL.

Inactive Ingredients

AQUA/WATER/EAU, CARBOMER, SODIUM C14-16 OLEFIN SULFONATE, COCAMIDOPROPYL BETAINR, SALICYLIC ACID, HYDROGENATED JOJOBA OIL, GLYCERIN, PHENOXYETHANOL, ETHYLHEXYLGLYCERIN, VITAMIN E ACETATE, ACTIVATED CHARCOAL, IRON OXIDE, PISTACIA LENTISCUS (MASTIC) GUM

* Please review the disclaimer below.