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NDC 36800-0497-15 Dry Scalp Care 10 mg/mL Details

Dry Scalp Care 10 mg/mL

Dry Scalp Care is a TOPICAL SHAMPOO in the HUMAN OTC DRUG category. It is labeled and distributed by TopCo. The primary component is PYRITHIONE ZINC.

Product Information

NDC	36800-0497
Product ID	36800-497_ddeaf669-7142-4981-b918-02cc3af53356
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	Dry Scalp Care
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
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 36800-0497-15 (36800049715)

Pricing Information	N/A
NDC Package Code	36800-497-15
Billing NDC	36800049715
Package	420 mL in 1 BOTTLE, PLASTIC (36800-497-15)
Marketing Start Date	2020-06-17
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 3300bfd5-ae84-4bc8-a4cd-05472b498fb7 Details

Claims

This TopCare product is laboratory tested to guarantee its highest quality. Your total satisfaction is quaranteed.

QUALITY

GUARANTEED

Active ingredient

Pyrithione zinc 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 if

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 Heard & Shoulders Dry Scalp Care 2 IN 1 pyrithione zinc Dandruff Shampoo & Conditioner.

adverse reactions section

DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL. 60007

TOPCO VIJA0320 QUESTIONS? 1-888-423-0139

principal display panel

TopCare

beauty

2-IN-1

DRY SCALP

DANDRUFF SHAMPOO

+ CONDITIONER

with Pyrithione Zinc

Compare to

HEAD & SOLDERS

Relieves dryness & flaking

Cleans & conditions

hair while moisturizers

help soothe the scalp

14.2 FL OZ (420 mL)

INGREDIENTS AND APPEARANCE

DRY SCALP CARE

pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-497
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 (800 CST) (UNII: 363Z2T48P7)
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:36800-497-15	420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/17/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part358H	06/17/2020

Labeler - TopCo (006935977)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(36800-497)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(36800-497)

Revised: 9/2022

Document Id: ddeaf669-7142-4981-b918-02cc3af53356

Set id: 3300bfd5-ae84-4bc8-a4cd-05472b498fb7

Version: 12

Effective Time: 20220921