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NDC 41163-0836-15 Dandruff 10.3 mg/mL Details

Dandruff 10.3 mg/mL

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

Product Information

NDC	41163-0836
Product ID	41163-836_7e8de714-97b9-4d8a-a392-a4865e854978
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	10.3
Active Ingredient Units	mg/mL
Substance Name	PYRITHIONE ZINC
Labeler Name	UNFI
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part358H
Listing Certified Through	2023-12-31

Package

Package Images

NDC 41163-0836-15 (41163083615)

Pricing Information	N/A
NDC Package Code	41163-836-15
Billing NDC	41163083615
Package	420 mL in 1 BOTTLE, PLASTIC (41163-836-15)
Marketing Start Date	2015-01-23
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 60a70b5f-4e0e-45f2-9908-204080c06877 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 manimum 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, Eucalyptus globulus leaf extract, methylchloroisothiazolinone, methylisothiazolinone

SPL UNCLASSIFIED SECTION

EQUALINE

Itchy Scalp 2 in 1 Dandruff Shampoo & Conditioner

*This product is not manufactured or distributed by Procter & Gamble, distributor of Head & Shoulders 2 in 1 Itchy Scalp Care Dandruff Shampoo & Conditioner

DISTRIBUTED BY SUPERVALU INC., EDEN PRAIRIE, MN 55344 USA

We're committed to your satisfaction and guarantee the quality of this product. Contact us at 1-877-932-7948, or www.supervalu-ourownbrands.com

Please have package available.

principal display panel

EQUALINE

compare to Head & Shoulders active ingredients*

Itchy Scalp 2 in 1 Dandruff Shampoo & Conditioner with added eucalyptus

to help soothe and protect against scalp itch

14.2 FL OZ (420 mL)

INGREDIENTS AND APPEARANCE

DANDRUFF

pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41163-836
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	10.3 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)
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41163-836-15	420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/23/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part358H	01/23/2015

Labeler - UNFI (006961411)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(41163-836)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(41163-836)

Revised: 3/2022

Document Id: 7e8de714-97b9-4d8a-a392-a4865e854978

Set id: 60a70b5f-4e0e-45f2-9908-204080c06877

Version: 12

Effective Time: 20220311