NDC 66738-434 Jack Black Balancing Foam Cleanser

Salicylic Acid

NDC Product Information

Jack Black Balancing Foam Cleanser with NDC 66738-434 is a a human over the counter drug product labeled by Jack Black Llc. The generic name of Jack Black Balancing Foam Cleanser is salicylic acid. The product's dosage form is gel and is administered via topical form.

Labeler Name: Jack Black Llc

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

Jack Black Balancing Foam Cleanser 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 .5 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)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • LACTIC ACID (UNII: 33X04XA5AT)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • LEVOMENOL (UNII: 24WE03BX2T)
  • CURCUMA LONGA WHOLE (UNII: W5488JUO8U)
  • CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)
  • ALOE (UNII: V5VD430YW9)

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: Jack Black Llc
Labeler Code: 66738
FDA Application Number: part358H 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: 02-12-2021 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 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.

Jack Black Balancing Foam Cleanser Product Label Images

Jack Black Balancing Foam Cleanser 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

Salicylic Acid 0.5%

Purpose

Acne Treatment

Uses

  • For the treatment of acneClears acne blemishes and blackheads.Penetrates pores to control acne blemishes and blackheads.Helps prevent new acne blemishes and blackheads from forming

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 use one topical medication at a time.

Keep Out Of Reach Of Children.

If product is swallowed, get medical help or contact a Poison Control Center right away

Directions

  • Dispense 1-2 Pumps into hand, apply to damp or dry face, and massage into skin in a circular motion.   Rinse thoroughly with warm water and pat dry. Use morning and evening.

Inactive Ingredients

Water, Disodium Cocoamphodiacetate, Cocamidopropyl Betaine, Butylene Glycol, Glycerin, Propanediol, Lactic Acid, Phenoxyethanol, Cocamidopropyl PG-Dimonium Chloride Phosphate, Ethylhexylglycerin, Bisabolol, Curcuma Longa (Turmeric) Root Extract, Camellia Sinensis Leaf Extract, Aloe Barbadensis Leaf Juice.

* Please review the disclaimer below.