PETE AND PEDRO- coal tar solution and menthol shampoo lotion/shampoo 
Cosco International, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Pete and Pedro Control Anti Itch Dandruff Shampoo

DRUG FACTS

Active Ingredients:

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

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

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:  For external use only.

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

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

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

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.

Other Information:  Store at room temperature between 68-78

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

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

8oz Label8oz Label8oz Label8oz Label

PETE AND PEDRO 
coal tar solution and menthol shampoo lotion/shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52261-0900
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC) COAL TAR0.001836 kg  in 1 kg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.00153 kg  in 1 kg
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52261-0900-10.260 kg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/24/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H01/24/2019
Labeler - Cosco International, Inc. (016433141)
Registrant - Cosco International, Inc. (016433141)
Establishment
NameAddressID/FEIBusiness Operations
Cosco International, Inc.016433141manufacture(52261-0900) , label(52261-0900) , pack(52261-0900)

Revised: 1/2019
Document Id: d06c1ac8-faa5-49a1-a0c0-72ed7c27826a
Set id: db5f10a3-2b69-41eb-94e6-a6498c62184b
Version: 2
Effective Time: 20190124
 
Cosco International, Inc.