HAPPY CAPPY- pyrithione zinc shampoo 
Pediatric Solutions, LLC

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.

----------

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

Principal Display Panel - 237 mL Bottle Label
HAPPY CAPPY 
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71566-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
pyrithione zinc (UNII: R953O2RHZ5) (pyrithione zinc - UNII:R953O2RHZ5) pyrithione zinc0.0095 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71566-100-08237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/07/2017
2NDC:71566-100-1115 mL in 1 PACKET; Type 0: Not a Combination Product09/29/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H12/07/2017
Labeler - Pediatric Solutions, LLC (080736513)
Establishment
NameAddressID/FEIBusiness Operations
Minimus Products LLC022997834MANUFACTURE(71566-100)
Establishment
NameAddressID/FEIBusiness Operations
Thibiant International, Inc083913913MANUFACTURE(71566-100)

Revised: 10/2021
Document Id: 7f0c8576-1b81-4de3-bc84-3388cbb12b16
Set id: 3d3828d8-ee15-4aff-99d1-a121f0102a00
Version: 4
Effective Time: 20211004
 
Pediatric Solutions, LLC