HAPPY CAPPY- pyrithione zinc shampoo

Happy Cappy by

Drug Labeling and Warnings

Happy Cappy by is a Otc medication manufactured, distributed, or labeled by Pediatric Solutions, LLC, Minimus Products LLC, kdc/one Chatsworth, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Pyrithione Zinc 0.95%

Purpose

Seborrheic Dermatitis and Dandruff

Uses

Helps eliminate scalp and skin scaling, redness, flaking, itching, and irritation associated with dandruff and seborrheic dermatitis.

Warnings

For external use only.

Ask a doctor before use if you have seborrheic dermatitis covering a large area of the body.

When using this product avoid contact with 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 call a Poison Control Center right away.

Directions

For best results use at least twice a week or as directed by a doctor.

• Wet hair thoroughly, massage on to scalp and skin, rinse.

Inactive ingredients

Water (Aqua), Glycerin, Sodium Lauroyl Methyl Isethionate, Sodium Laurylglucosides Hydroxypropylsulfonate, Cocamidopropyl Hydroxysultaine, Acrylates Copolymer, Pyrus Malus (Apple) Fruit Extract, Phenoxyethanol, Sodium Chloride, Guar Hydroxypropyltrimonium Chloride, Sodium Hydroxide, Dipotassium Glycyrrhizate, Panthenol, Ethylhexylglycerin, Citric Acid.

Principal Display Panel - 237 mL Bottle Label

Dr. Eddie's
Happy
Cappy®

A Pediatrician's Solution

fights flakes

MEDICATED SHAMPOO & BODY WASH

for Seborrheic Dermatitis & Dandruff

Pyrithione Zinc

with Licorice Root Extract to soothe redness

8 fl. oz. (237 ml.)

FRAGRANCE FREE DYE FREE DERMATOLOGIST TESTED

INGREDIENTS AND APPEARANCE

HAPPY CAPPY 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71566-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
pyrithione zinc (UNII: R953O2RHZ5) (pyrithione zinc - UNII:R953O2RHZ5)	pyrithione zinc	0.0095 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
Sodium Lauroyl Methyl Isethionate (UNII: II6VCD3S6R)
Cocamidopropyl Hydroxysultaine (UNII: 62V75NI93W)
Acrylic Acid/Isophorone Diisocyanate/PEG-27 Copolymer (UNII: R0R8I3X29J)
Apple (UNII: B423VGH5S9)
Phenoxyethanol (UNII: HIE492ZZ3T)
Sodium Chloride (UNII: 451W47IQ8X)
Guar Hydroxypropyltrimonium Chloride (1.7 Substituents Per Saccharide) (UNII: B16G315W7A)
Sodium Hydroxide (UNII: 55X04QC32I)
Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX)
Panthenol (UNII: WV9CM0O67Z)
Ethylhexylglycerin (UNII: 147D247K3P)
Citric Acid Monohydrate (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71566-100-08	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/07/2017
2	NDC: 71566-100-11	15 mL in 1 PACKET; Type 0: Not a Combination Product	09/29/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	12/07/2017

Labeler - Pediatric Solutions, LLC (080736513)

Establishment
Name	Address	ID/FEI	Business Operations
Minimus Products LLC		022997834	MANUFACTURE(71566-100)

Establishment
Name	Address	ID/FEI	Business Operations
Thibiant International, Inc		083913913	MANUFACTURE(71566-100)