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NDC 36800-0281-15 Dandruff 10 mg/mL Details

Dandruff 10 mg/mL

Dandruff is a TOPICAL SHAMPOO in the HUMAN OTC DRUG category. It is labeled and distributed by Topco Associates LLC. The primary component is PYRITHIONE ZINC.

Product Information

NDC	36800-0281
Product ID	36800-281_733bdd8e-27f9-4106-b9a7-b13947c3003b
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	Dandruff
Proprietary Name Suffix	n/a
Non-Proprietary Name	Pyrithione zinc
Product Type	HUMAN OTC DRUG
Dosage Form	SHAMPOO
Route	TOPICAL
Active Ingredient Strength	10
Active Ingredient Units	mg/mL
Substance Name	PYRITHIONE ZINC
Labeler Name	Topco Associates 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 36800-0281-15 (36800028115)

Pricing Information	N/A
NDC Package Code	36800-281-15
Billing NDC	36800028115
Package	420 mL in 1 BOTTLE, PLASTIC (36800-281-15)
Marketing Start Date	2002-05-28
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 706b856c-ce89-4860-bc5d-9803deb469e7 Details

Drug Facts

Top Care

Dandruff Care for Great Looking Hair

TopCare Dandruff Shampoo Dry Scalp formula

helps relieve scalp dryness, itch irritation and

helps prevent flakes for clean, manageable hair every day

Active Ingredient

Pyrithione zince 1%

Purpose

Anti-Dandruff

Use

helps prevent recurrence of flaking and itching associated with dandruff

Warnings

For external use only

When using this product

do not get into eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor

condition worsens or does not improve after regular use as directed

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

shake well
for maximum dandruff control, use every time you shampoo
wet hair, massage onto scalp, rinse, repeat if desired
for best results use at least twice a week or as directed by a doctor

Inactive ingredients

water, sodium lauryl sulfate, sodium laureth sulfate, glycol distearate, sodium chloride, zinc carbonate, sodium xylenesulfonate, amodimethicone, cocamidopropyl betaine, fragrance, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, citric acid, Prunus amygdalus dulcis (sweet almond) oil, methylchloroisothiazolinone, methylisothiazolinone

Disclaimer

This product is not manufactured or distributed by Procter + Gamble, distributor of Head + Shoulders

Adverse reactions

DISTRIBUTED BY TOPCO ASSOCIATES LLC

7711 GROSS POINT ROAD, SKOKIE, IL 60077

Questions

1-888-423-0139 [email protected]

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELD GROVE VILLAGE, IL 60007

topcare@ topco.com www.topcarebrand.com

principal display panel

Top Care

beauty

DRY SCALP

GENTLE DANDRUFF SAMPOO

with Pyrithione Zinc

Compare to

HEAD & SHOULDERS

with Almond Oil

Cleans hair while moisturizer help sooth the scalp

14.2 FL OZ (420 mL)

INGREDIENTS AND APPEARANCE

DANDRUFF

pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-281
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	10 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ZINC CARBONATE (UNII: EQR32Y7H0M)
SODIUM XYLENESULFONATE (UNII: G4LZF950UR)
AMODIMETHICONE (1300 CST) (UNII: 3V7U636DWN)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM BENZOATE (UNII: OJ245FE5EU)
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)
MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ALMOND OIL (UNII: 66YXD4DKO9)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:36800-281-15	420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/28/2002

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part358H	05/28/2002

Labeler - Topco Associates LLC (006935977)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(36800-281)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(36800-281)

Revised: 6/2022

Document Id: 733bdd8e-27f9-4106-b9a7-b13947c3003b

Set id: 706b856c-ce89-4860-bc5d-9803deb469e7

Version: 11

Effective Time: 20220608