Head and Shoulders ® Detox & Refresh Shampoo

Head and Shoulders ® Detox & Refresh Shampoo

Drug Labeling and Warnings

Drug Details

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HEAD AND SHOULDERS DETOX AND REFRESH- pyrithione zinc shampoo 
The Procter & Gamble Manufacturing Company

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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Head and Shoulders ® Detox & Refresh Shampoo

Drug Facts

Active ingredient

Pyrithione zinc 1%

Purpose

Anti-dandruff

Uses

helps prevent recurrence of flaking and itching associated with dandruff.

Warnings

For external use only.

When using this product

• avoid contact with 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 of this product as directed.

Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• for best results use at least twice a week or as directed by a doctor.
• for maximum dandruff control, use every time you shampoo.
• shake before use.
• wet hair, massage onto scalp, rinse, repeat if desired.

Inactive ingredients

Water, sodium laureth sulfate, zinc carbonate,glycol distearate, cocamide MEA, cocamidopropyl betaine, fragrance, sodium xylenesulfonate, sodium chloride, dimethicone, menthol, guar hydroxypropyltrimonium chloride, sodium benzoate, polyquaternium-10, stearyl alcohol, magnesium carbonate hydroxide, cetyl alcohol, mentha piperita (peppermint) oil,

mentha arvensis leaf oil, methylchloroisothiazolinone, methylisothiazolinone, yellow 5, blue1.

Questions (or comments)?

1-800-723-9569

Dist. by PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 380 mL Bottle Label

head &

shoulders

PYRITHIONE ZINC DANDRUFF SHAMPOO

DETOX & REFRESH

SHAMPOO

REINVIGORATES SCALP AND DEEPLY

CLEANSES HAIR TO RESTORE SHINE

WITH CUCUMBER ESSENCE

AND MENTHOL

FLAKE FREE

UP TO 100%

GUARANTEED

12.8 FL OZ (380 mL)

HEAD AND SHOULDERS DETOX AND REFRESH 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69423-321
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
WATER (UNII: 059QF0KO0R)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
ZINC CARBONATE (UNII: EQR32Y7H0M)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM XYLENESULFONATE (UNII: G4LZF950UR)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
DIMETHICONE (UNII: 92RU3N3Y1O)
SODIUM BENZOATE (UNII: OJ245FE5EU)
MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
MENTHOL (UNII: L7T10EIP3A)
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)
POLYQUATERNIUM-10 (30000 MPA.S AT 2%) (UNII: C7RDC8Y4JS)
CETYL ALCOHOL (UNII: 936JST6JCN)
MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)
PEPPERMINT OIL (UNII: AV092KU4JH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69423-321-38	380 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/08/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	01/08/2019

Labeler - The Procter & Gamble Manufacturing Company (004238200)

Revised: 12/2018

Document Id: 7cd755b7-58f2-16f6-e053-2a91aa0ac612

34390-5

Set id: 7cd755b7-58f1-16f6-e053-2a91aa0ac612

Version: 1

Effective Time: 20181212

 

The Procter & Gamble Manufacturing Company