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NDC 37808-0612-35 2 in 1 Dandruff 1 g/mL Details

2 in 1 Dandruff 1 g/mL

2 in 1 Dandruff is a TOPICAL SHAMPOO in the HUMAN OTC DRUG category. It is labeled and distributed by H E B. The primary component is PYRITHIONE ZINC.

Product Information

NDC	37808-0612
Product ID	37808-612_d65c3ac3-f9aa-408e-94f0-36a8e5c99de2
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	2 in 1 Dandruff
Proprietary Name Suffix	n/a
Non-Proprietary Name	Pyrithione zinc
Product Type	HUMAN OTC DRUG
Dosage Form	SHAMPOO
Route	TOPICAL
Active Ingredient Strength	1
Active Ingredient Units	g/mL
Substance Name	PYRITHIONE ZINC
Labeler Name	H E B
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 37808-0612-35 (37808061235)

Pricing Information	N/A
NDC Package Code	37808-612-35
Billing NDC	37808061235
Package	700 mL in 1 BOTTLE, PLASTIC (37808-612-35)
Marketing Start Date	2016-10-19
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a58b9119-2adb-459f-86f4-95df28a430c5 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, yellow 5

Questions?

Call 1-888-593-0593

SPL UNCLASSIFIED SECTION

Dandruff 2 in 1 Clean Apple

Dandruff Care for Great Looking Hair.

Helps relieve scalp dryness, itch, irritation and helps prevent flakes.

MADE WITTH PRIDE AND CARE FOR H-E-B,

SAN ANTONIO, TX 78204

100% GUARANTEE

If you aren't completely pleased with this product, we'll be happt to replace it or refund your money. You have our word on it.

principal display panel

H-E-B

Dandruff 2 in 1 Shampoo + Conditioner

With Pyrithione Zinc

CLEAN APPLE

REFRESHING AND CLEAN

Leaves Hair Healthy Looking & Fights Dry Scalp

23.7 FL OZ (1.4 PT) 700 mL

INGREDIENTS AND APPEARANCE

2 IN 1 DANDRUFF

pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37808-612
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	1 g 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)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:37808-612-35	700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/19/2016
2	NDC:37808-612-15	420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/19/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part358H	10/19/2016

Labeler - H E B (007924756)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(37808-612)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(37808-612)

Revised: 3/2022

Document Id: d65c3ac3-f9aa-408e-94f0-36a8e5c99de2

Set id: a58b9119-2adb-459f-86f4-95df28a430c5

Version: 9

Effective Time: 20220301