NDC 52261-0900 Pete And Pedro

Coal Tar Solution And Menthol Shampoo

NDC Product Code 52261-0900

NDC 52261-0900-1

Package Description: .26 kg in 1 BOTTLE, PLASTIC

NDC Product Information

Pete And Pedro with NDC 52261-0900 is a a human over the counter drug product labeled by Cosco International, Inc.. The generic name of Pete And Pedro is coal tar solution and menthol shampoo. The product's dosage form is lotion/shampoo and is administered via topical form.

Labeler Name: Cosco International, Inc.

Dosage Form: Lotion/shampoo - A lotion dosage form which has a soap or detergent that is usually used to clean the hair and scalp; it is often used as a vehicle for dermatologic agents.

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.

Pete And Pedro 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.

  • COAL TAR .001836 kg/kg
  • MENTHOL .00153 kg/kg

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)
  • GUAR GUM (UNII: E89I1637KE)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • HYDROXYMETHYL CELLULOSE (UNII: 273FM27VK1)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • COCO MONOETHANOLAMIDE (UNII: C80684146D)
  • SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
  • ZINC STEARATE (UNII: H92E6QA4FV)
  • PEPPERMINT OIL (UNII: AV092KU4JH)
  • TEA TREE OIL (UNII: VIF565UC2G)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

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: Cosco International, Inc.
Labeler Code: 52261
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: 01-24-2019 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.

Pete And Pedro Product Label Images

Pete And Pedro 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

Drug Facts

Active Ingredients:Coal Tar Solution 1.8%..................Controls the symptoms of dandruff, seborrheic dermatitis and psoriasisMenthol 1.5%..............................Contols scalp itch

Otc - Purpose

Uses:  Product relieves and helps stop the recurrence of scalp itching, irritation, redness, flaking and scaling associated with dandruff, seborrheic dermatitis and psoriasis.  Provide relief of itching due to dandruff.

Warnings

Warnings:  For external use only.

WARNING:  This product contains a chemical known to the State of California to cause cancer.

Otc - Do Not Use

Do not use for prolonged periods without consulting a doctor or with other forms of psoriasis therapy such as ultraviolet radiation or prescription drugs unless directed to do so by a physician.

Otc - Ask Doctor

Ask a doctor before use if you have a conditiion that covers a large area of the body.

Indications & Usage

When using this product avoid contact with the eyes.  If contact occurs, rinse thoroughly with water.  Use caution in exposing skin to sunlight after applying.  It may increase you tendency to sunburn for up to 24 hours after application.

Otc - Stop Use

Stop use and ask doctor if condition worsens or does not improve after regular use of the product as directed.

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.

Dosage & Administration

DIRECTIONS:  Shake well and apply shampoo to wet hair.  Gently massage it into hair and scalp to work up a lather.  Rinse hair thoroughly and repeat for best results.  Use at least twice a week or as directed by a doctor.

Storage And Handling

Other Information:  Store at room temperature between 68-78

Inactive Ingredient

Inactive Ingredients:  Caprylyl Glycol, Citric Acid, Cocamide MEA, Cocamidopropyl Betaine, Ethanol, FD&C Blue #1, Glycerin, Guar Gum, Hydroxypropyl Methylcellulose, Melaleuca Alternafolia (Tea Tree) Leaf Oil, Mentha Piperita (Peppermint) Oil, Phenoxyethanol, Sodium Laureth Sulfate, Water, Zinc Stearate

Otc - Questions

Questions:  1 (404) 918-0020 or www.peteandpedro.com

* Please review the disclaimer below.

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