NDC 11489-176 No7 Laboratories Acne Treatment

Salicylic Acid

NDC Product Information

No7 Laboratories Acne Treatment with NDC 11489-176 is a a human over the counter drug product labeled by Bcm Ltd. The generic name of No7 Laboratories Acne Treatment is salicylic acid. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Bcm Ltd

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

No7 Laboratories Acne Treatment 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 1 g/50g

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)
  • KAOLIN (UNII: 24H4NWX5CO)
  • OCTYLDODECANOL (UNII: 461N1O614Y)
  • ALCOHOL (UNII: 3K9958V90M)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
  • STEARETH-21 (UNII: 53J3F32P58)
  • TRIMETHYLOLPROPANE TRIACRYLATE (UNII: 4B67KGL96S)
  • C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
  • HAMAMELIS VIRGINIANA LEAF WATER (UNII: 8FP93ED6H2)
  • POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
  • STEARETH-2 (UNII: V56DFE46J5)
  • BETAINE (UNII: 3SCV180C9W)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
  • .ALPHA.-GLUCAN OLIGOSACCHARIDE (UNII: S95658MI3W)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • LAURETH-7 (UNII: Z95S6G8201)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • BISABOLOL OXIDE A (UNII: 16AE65F94Y)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4)
  • TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
  • FRUCTOSE (UNII: 6YSS42VSEV)
  • DEXTROSE (UNII: IY9XDZ35W2)

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.
  • 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: Bcm Ltd
Labeler Code: 11489
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: 11-04-2020 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’.

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No7 Laboratories Acne Treatment Product Label Images

No7 Laboratories Acne Treatment 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 Ingredients

Active ingredient PurposeSalicylic acid Acne Treatment

Dosage

2%

Uses

UsesFor the treatment of acne

Warnings

For external use onlyWhen using this productskin irritation and dryess is more likely to occur if you use anohter topical acne medication at the same time. If irritation occurs, only use on topical acne medication at a time.Avoid contact with eyes.If contact occurs, flush thoroughly with water.

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

DirectionsClean the skin thoroughly before applying the product.Cover the entire affected area with a thin layer one to three times daily.Because 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 doctor.If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Inactive Ingredients

Aqua (Water), Kaolin, Octyldodecanol, Alcohol denat., Cetearyl alcohol, Butylene glycol, Polyacrylamide, Steareth-21, Polyacrylate crosspolymer-6, C13-14 isoparaffin, Hamamelis virginiana (Witch hazel) water, Potassium hydroxide, Steareth-2, betaine, Dimethicon, Ammonium glycyrrhizate, Alpha-glucan oligosaccharide, Phenoxyethanol, Laureth-7, Caprylyl glycol, Bisabolol, Xanthan gum, Alcohol, Exylhexylglycerin, Tetrasodium EDTA, T-butyl alcohol, Fructose, Glucose, CI 14700 (Red 4), CI 42090 (Blue 1).

Questions

USA: Questions? 1-866-752-6687

Description

No7LABORATORIESCLINICALLY PROVENCLINICALLY PROVENACNE TREATMENT2% Salicylic AcidReduce the appearance of acne & blemishes overnightDermatologist approved2% SALICYLIC ACID+ PRE-BIOTIC TECHNOLOGY50 ml e 1.69 US Fl. Oz.No7 Laboratories Acne Treatment is clinically proven to receal healthier and clearer looking skin. Dermatologist approved this medicated 2% Salicylic Acid treatment visibly reduces the appearance of acne overnight. With pre-biotic technology, feed your skin for a nourished, blanaced and health-looking complexion.- Reduces the apperance of acne, blemishes & breakouts overnight- Renews skin's surface to clear pores, helping to prevent new blemishes forming- Excess oil is reduced for shine-free skin- Restores balance to troubled skinPOWERED BY:2% SALICYLIC ACID+ PRE-BIOTIC TECHNOLOGYIn 1 week women agreed their skin's appearance had been transformed, and after 4 weeks saw their clearest complexion in years.Fragrance free and suitable for sensitive skin.For best results: In the evening after cleansing skin apply a thin layer of the product to troublesome area. Leav on overnight and rinse away in the morning. Use 2-3 times a week.

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