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NDC 69842-0612-15 Dandruff 2 in 1 10 mg/mL Details

Dandruff 2 in 1 10 mg/mL

Dandruff 2 in 1 is a TOPICAL SHAMPOO in the HUMAN OTC DRUG category. It is labeled and distributed by CVS Pharmnacy, Inc. The primary component is PYRITHIONE ZINC.

Product Information

NDC	69842-0612
Product ID	69842-612_1ac1edc0-ce3f-41bd-8580-454a5d13c671
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 2 in 1
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	CVS Pharmnacy, Inc
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part358H
Listing Certified Through	2022-12-31

Package

Package Images

NDC 69842-0612-15 (69842061215)

Pricing Information	N/A
NDC Package Code	69842-612-15
Billing NDC	69842061215
Package	420 mL in 1 BOTTLE, PLASTIC (69842-612-15)
Marketing Start Date	2018-05-12
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 54e205f9-b877-4967-b1c8-be9176afb4d2 Details

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

Active ingrediet

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

disclaimer

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

Adverse reactions

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

2018 CVS/Pharmacy

CVS.com 1-800-SHOP CVS

Made in the U.S.A. with U.S. and foreign components

principal display panel

CVS

Health

Compare to

Head & Shoulders

2 in 1 Green Apple

Clean Apple

Dandruff Shampoo &

Conditioner

PYRITHION ZINC

Helps relieve scalp dryness, itching & light flaking
Paraben & phthalate free

2-in1

14.2 FL OZ

(420 mL)

INGREDIENTS AND APPEARANCE

DANDRUFF 2 IN 1

pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69842-612
Route of Administration	TOPICAL

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69842-612-15	420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/12/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part358H	05/12/2018

Labeler - CVS Pharmnacy, Inc (062312574)

Registrant - Vi-Jon, Inc (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, Inc		790752542	manufacture(69842-612)

Revised: 9/2018

Document Id: 1ac1edc0-ce3f-41bd-8580-454a5d13c671

Set id: 54e205f9-b877-4967-b1c8-be9176afb4d2

Version: 1

Effective Time: 20180904