NDC 11344-054 Blackhead Scrub

Salicylic Acid (1%)

NDC Product Information

Blackhead Scrub with NDC 11344-054 is a a human over the counter drug product labeled by Vi-jon. The generic name of Blackhead Scrub is salicylic acid (1%). The product's dosage form is cream and is administered via respiratory (inhalation) form.

Labeler Name: Vi-jon

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.

Blackhead 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 10 mg/g

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)
  • HYDRATED SILICA (UNII: Y6O7T4G8P9)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • CETYL ACETATE (UNII: 4Q43814HXS)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
  • ACETYLATED LANOLIN ALCOHOLS (UNII: SNN716810P)
  • POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • D&C RED NO. 33 (UNII: 9DBA0SBB0L)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Administration Route(s)

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

  • Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.
  • Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.

Product Labeler Information

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

Labeler Name: Vi-jon
Labeler Code: 11344
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: 09-01-2020 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.

Blackhead Scrub Product Label Images

Blackhead 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 (1%)

Purpose

Acne medication

Use

  • For treatment of acne

Warnings

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 se topical acne medication at a time.

Keep Out Of Reach Of Children.

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

Directions

  • Moisten face with water.  Apply product with wet fingertips and massage over face.  Rinse well and pat dry.avoid contact with the eyes.  If contact occurs, flush throughly with water.

Inactive Ingredients

Water, hydrated silica, glycerin, glyceryl stearate SE, cetearyl alcohol, cetyl alcohol, decyl glucoside, cocamidopropyl betaine, triethanolamine, glyceryl stearate, PEG-100 stearate, cetyl acetate, benzyl alcohol, fragrance, carbomer, acetylated lanolin alcohol, ceteareth-20, polysorbate 60, propylene glycol, disodium EDTA, benzoic acid, Camellia sinensis leaf extract, red 33, blue 1, yellow 5

Adverse Reactions

This product is not manufactured or distributed by Unilever, distributo of St. Ives Blackhead Clearing Green Tea ScrubDistributed by:Vi-Jon, Inc.,St. Louis MO 63114

* Please review the disclaimer below.