Drug Facts

Active Ingredients

Coal Tar Solution 6.25% (Coal Tar 0.50%)

Purpose

Anti-dandruff

Uses

For relief of the symptoms of dandruff

Warnings:

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

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

When using this product

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

Stop use and ask a doctor if

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

Keep out of reach of children.

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

If pregnant or breast-feeding,

ask a health professional before use.

Directions:

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

Other information:

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

Inactive ingredients:

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?

(404) 918-0020

Package Labelling:

PETE AND PEDRO CONTROL ANTI ITCH DANDRUFF
coal tar shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:84503-508
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC)	COAL TAR	62.5 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL (UNII: L7T10EIP3A)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLYCOL STEARATE (UNII: 0324G66D0E)
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (UNII: B16G315W7A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PEPPERMINT OIL (UNII: AV092KU4JH)
BERGAMOT OIL (UNII: 39W1PKE3JI)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:84503-508-00	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/25/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M032	06/25/2024

Labeler - PETE AND PEDRO LLC (080927195)

Pete & Pedro Control Anti-Itch Dandruff Shampoo