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NDC 71566-0100-08 Happy Cappy 0.0095 g/mL Details

Happy Cappy 0.0095 g/mL

Happy Cappy is a TOPICAL SHAMPOO in the HUMAN OTC DRUG category. It is labeled and distributed by Pediatric Solutions, LLC. The primary component is PYRITHIONE ZINC.

Product Information

NDC	71566-0100
Product ID	71566-100_ea334abe-d8c3-47c5-a09b-3e382f2911dd
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Happy Cappy
Proprietary Name Suffix	n/a
Non-Proprietary Name	pyrithione zinc
Product Type	HUMAN OTC DRUG
Dosage Form	SHAMPOO
Route	TOPICAL
Active Ingredient Strength	0.0095
Active Ingredient Units	g/mL
Substance Name	PYRITHIONE ZINC
Labeler Name	Pediatric Solutions, LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part358H
Listing Certified Through	2024-12-31

Package

Package Images

NDC 71566-0100-08 (71566010008)

Pricing Information	N/A
NDC Package Code	71566-100-08
Billing NDC	71566010008
Package	237 mL in 1 BOTTLE, PLASTIC (71566-100-08)
Marketing Start Date	2017-12-07
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 3d3828d8-ee15-4aff-99d1-a121f0102a00 Details

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

Principal Display Panel - 237 mL Bottle Label

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part358H	12/07/2017

Labeler - Pediatric Solutions, LLC (080736513)

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

Name	Address	ID/FEI	Business Operations
Establishment
kdc/one Chatsworth, Inc.		118542196	MANUFACTURE(71566-100)

Revised: 10/2021

Document Id: ea334abe-d8c3-47c5-a09b-3e382f2911dd

Set id: 3d3828d8-ee15-4aff-99d1-a121f0102a00

Version: 5

Effective Time: 20211004