NDC 55628-9155 Therazcream

Triclosan

NDC Product Code 55628-9155

NDC Product Information

Therazcream with NDC 55628-9155 is a a human over the counter drug product labeled by Cal Pharma. The generic name of Therazcream is triclosan. The product's dosage form is cream and is administered via topical form.

Labeler Name: Cal Pharma

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.

Therazcream 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.

  • TRICLOSAN .3 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.

  • CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
  • ALCOHOL (UNII: 3K9958V90M)
  • ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • CARBOMER 940 (UNII: 4Q93RCW27E)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • PEG-75 STEARATE (UNII: OT38R0N74H)
  • CETETH-20 (UNII: I835H2IHHX)
  • STEARETH-20 (UNII: L0Q8IK9E08)
  • DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • GLYCERETH-26 (UNII: NNE56F2N14)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • CERESIN (UNII: Q1LS2UJO3A)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
  • VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
  • SODIUM METABISULFITE (UNII: 4VON5FNS3C)
  • SORBIC ACID (UNII: X045WJ989B)
  • STEARETH-21 (UNII: 53J3F32P58)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • UREA (UNII: 8W8T17847W)
  • WATER (UNII: 059QF0KO0R)
  • XANTHAN GUM (UNII: TTV12P4NEE)

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: Cal Pharma
Labeler Code: 55628
FDA Application Number: part333A 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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 04-17-2013 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.

Therazcream Product Label Images

Therazcream 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

TRICLOSAN 0.3%

Otc - Purpose

PURPOSEANTIBACTERIAL

Indications & Usage

USETO DECREASE BACTERIA ON SKIN.

Warnings

WARNINGSFOR EXTERNAL USE ONLY

Otc - When Using

WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER.

Otc - Stop Use

STOP USE AND ASK A DOCTOR IF IRRITATION AND REDNESS DEVELOP.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN. IF PRODUCT IS SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

Dosage & Administration

DIRECTIONS: APPLY A SMALL AMOUNT OF CREAM TO THE SKIN AND RUB IN GENTLY.

Inactive Ingredient

INGREDIENTSAcrylates/C10-30 Alkyl Acrylates Crosspolymer, Alcohol Denat., Alkyl Benzoate, Aloe Barbadensis Leaf Juice, Benzyl Alcohol, Butyrospermum Parkii (Shea Butter) Fruit, Caprylic/Capric Triglycerides, Carbomer, Cetearyl Alcohol and Polysorbate 60, Cetyl Alcohol, Cetyl Alcohol (and) Glyceryl Stearate (and) PEG-75 Stearate (and) Ceteth-20 (and) Steareth-20, Diazolidinyl Urea, Dimethicone, Fragrance, Glycereth-26, Glycerin, Magnesium Aluminum Silicate, Mineral Oil, Ozokerite, Phenoxyethanol (and) Benzoic Acid (and) Ethylhexylglycerin (and) Glycereth-2 Cocoate, Polysorbate 20, Potassium Hydroxide, Retinyl Palmitate, Sodium Metabisulfite, Sorbic Acid, Steareth 2, Stearth-21, Stearyl Alcohol, Tocopheryl Acetate (Vitamin E Acetate), Urea, Water, Xanthan Gum

* Please review the disclaimer below.