PETE AND PEDRO- coal tar solution and menthol shampoo lotion/shampoo

Pete and Pedro by

Drug Labeling and Warnings

Pete and Pedro by is a Otc medication manufactured, distributed, or labeled by Cosco International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Active Ingredients:

Coal Tar Solution 1.8%..................Controls the symptoms of dandruff, seborrheic dermatitis and psoriasis

Menthol 1.5%..............................Contols scalp itch

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.

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.

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.

STOP USE

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

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

QUESTIONS

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

WARNINGS

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PETE AND PEDRO 
coal tar solution and menthol shampoo lotion/shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52261-0900
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC)	COAL TAR	0.001836 kg  in 1 kg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.00153 kg  in 1 kg

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52261-0900-1	0.260 kg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/24/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	01/24/2019

Labeler - Cosco International, Inc. (016433141)

Registrant - Cosco International, Inc. (016433141)

Establishment
Name	Address	ID/FEI	Business Operations
Cosco International, Inc.		016433141	manufacture(52261-0900) , label(52261-0900) , pack(52261-0900)