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NDC 41250-0941-15 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 Meijer Distribution, Inc. The primary component is PYRITHIONE ZINC.

Product Information

NDC	41250-0941
Product ID	41250-941_695b27f2-6f0b-425e-8db9-4e1355144a88
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	Meijer Distribution, Inc
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 41250-0941-15 (41250094115)

Pricing Information	N/A
NDC Package Code	41250-941-15
Billing NDC	41250094115
Package	420 mL in 1 BOTTLE, PLASTIC (41250-941-15)
Marketing Start Date	2014-12-17
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 7261ac36-585f-4fb7-b498-337f83abef98 Details

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, methylchloroisothiazolinone, methylisothiazolinone, blue 1, red 33

Questions?

1-888-593-0593

Claims

Multiple benefit formula to help:

Fight dry scalp

Calm itch

Relieve irritation

Soothe and reduce redness

Reduce oiliness

Prevent flakes

Leave hair healthy looking

Disclaimer

*This product is not manufactured or distributed by the Procter & Gamble Company, owner of the registered trademark Head & Shoulders

DIST. BY MEIJER DISTRIBUTION, INC

GRAND RAPIDS, MI 49544

www.meijer.com

253.001/253AB-AC

principal display panel

meijer

Smooth Sea Scent dandruff shampoo For Men

pyrithione zinc

dandruff shampoo 2 in 1

an energizing clean enhanced with a masculine scent

*COMPARE TO THE ACTIVE INGREDIENT OF HEAD & SHOULDERS

14.2 FL OZ (420 mL)

INGREDIENTS AND APPEARANCE

DANDRUFF

pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41250-941
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)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41250-941-15	420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/17/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part358H	12/17/2014

Labeler - Meijer Distribution, Inc (006959555)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(41250-941)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(41250-941)

Revised: 4/2022

Document Id: 695b27f2-6f0b-425e-8db9-4e1355144a88

Set id: 7261ac36-585f-4fb7-b498-337f83abef98

Version: 10

Effective Time: 20220413