DRY SCALP CARE- pyrithione zinc shampoo
FOODHOLD U.S.A. LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Care One 296.007 296AT AV

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 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, the distributor of Head & Shoulders 2 in 1 Dry Scalp Care Dandruff Shampoo & Conditioner

Adverse reactions

DISTRIBUTED BY FOODOLD U.S.A, LLC

LANDOVER, MD 20785

1-877-846-9949

Quality guaranteed or your money back.

296.007/296AT

principal display panel

CAREONE

dry scalp 2 in 1

Dandruff

shampoo

plus conditioner

moisturizes to help

relieve dry scalp

pyrithione zinc

helps prevet flakes

with added almond oil

Compare to Head & Shoulders

2 in 1 Dry Scalp Care Dandruff

Shampoo & Conditioner

14.2 FL OZ (420 mL)

image description

DRY SCALP CARE
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41520-296
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:41520-296-15	420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/05/2009	09/20/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part358H	06/05/2009	09/20/2023

Labeler - FOODHOLD U.S.A. LLC (809183973)

Registrant - Vi-Jon (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon		790752542	manufacture(41520-296)

Revised: 9/2023

Document Id: 492c1c07-03be-46e3-95d7-8142f3433e25

Set id: da39fb4e-4658-40f9-a3d3-3787e419ba71

Version: 8

Effective Time: 20230920

FOODHOLD U.S.A. LLC