Pete and Pedro Control Anti Itch Dandruff

Manufacturer
PETE AND PEDRO LLC
Effective date
2024-07-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:14:40

Label at a glance#

ProductPete and Pedro Control Anti Itch Dandruff
Active ingredientCOAL TAR
Label structure8 sections

Indications and uses

For relief of the symptoms of dandruff

Dosage and administration

Apply to affected areas one to four times daily or as directed by a doctor.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Coal Tar Solution 6.25% (Coal Tar 0.50%)

Purpose

OTC - PURPOSE SECTION

Anti-dandruff

Uses

INDICATIONS & USAGE SECTION

  • For relief of the symptoms of dandruff

Warnings:

WARNINGS SECTION

For external use only.

Use caution in exposing skin to sunlight after applying this product. It may increase your tendency to sunburn for upto 24 hours after application.

Do not use for prolonged periods without consulting doctor.

Do not use

OTC - DO NOT USE SECTION

  • before consulting your doctor, if condition covers a large area of the body.

When using this product

OTC - WHEN USING SECTION

  • Avoid contact with the eyes.
  • If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens or does not improve after regular use of this product as directed.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Apply to affected areas one to four times daily or as directed by a doctor.

Other information:

SPL UNCLASSIFIED SECTION

  • Protect the product in this container from excessive heat and direct sun.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Aqua (Deionized Water), Sodium Lauryl Sulfate, Cocamidopropyl Betaine, Glycerin, SD-Alcohol 408, Menthol, Sodium Chloride, Cocamide MEA, Melaleuca Alternifolia (Tea Tree) Oil, Phenoxyethanol, Caprylyl Glycol, Glycol stearate, Guar Hydroxypropyltrimonium Chloride, Polysorbate 80, Mentha Piperita (Peppermint) Oil, Citrus Aurantium (Bergamot) Oil, FD&C Blue #1.

Questions?

OTC - QUESTIONS SECTION

(404) 918-0020

Package  Labelling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label.jpgLabel.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
309381coal tar 0.5 % Medicated ShampooPSN1
309381coal tar 5 MG/ML Medicated ShampooSCD1
309381coal tar 0.5 % Medicated ShampooSY1
309381crude coal tar 0.5 % (coal tar solution 2.5 % ) Medicated ShampooSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84503-508-00Pete and Pedro Control Anti Itch Dandruff236 mL in 1 BOTTLESHAMPOO2361

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84503-508PETE AND PEDRO CONTROL ANTI ITCH DANDRUFF (COAL TAR) SHAMPOO [PETE AND PEDRO LLC]1Current NDC, 1 package rows20240704_34ec83c1-31b9-4ecc-8bd2-898fd85364ba.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84503-50884503-508-00

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pete and Pedro Control Anti Itch DandruffCOAL TARPETE AND PEDRO LLC34ec83c1-31b9-4ecc-8bd2-898fd85364ba2024-07-02WarningsExact identifier
ndc (package): 84503-508-00
ndc (product): 84503-508
ndc11 (package): 84503050800
spl id: 1c403c65-8b3f-5f3c-e063-6394a90a487b
spl set id: 34ec83c1-31b9-4ecc-8bd2-898fd85364ba

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.