DailyMed - HEAD AND SHOULDERS DUAL SACHETS SMOOTH AND SILKY- pyrithione zinc kit

Contains inactivated NDC Code(s)
NDC Code(s): 37000-094-10, 69423-103-10, 69423-296-01
Packager: The Procter & Gamble Manufacturing Company

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None
Marketing Status: OTC monograph final

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.

Drug Label Information

Updated January 9, 2020

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SPL UNCLASSIFIED SECTION

head &
shoulders
instant relief
pyrithione zinc dandruff 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, sodium lauryl sulfate, cocamide MEA, zinc carbonate, glycol distearate, fragrance, sodium xylenesulfonate, dimethicone, cetyl alcohol, guar hydroxypropyltrimonium chloride, magnesium sulfate, sodium chloride, sodium benzoate, magnesium carbonate hydroxide, benzyl alcohol, mentha piperita (peppermint) oil, menthol, mentha arvensis leaf oil, methylchloroisothiazolinone, methylisothiazolinone, yellow 5, blue 1.
Questions (or comments)?

1-800-723-9569
SPL UNCLASSIFIED SECTION

head &
shoulders
instant relief
pyrithione zinc dandruff conditioner

Drug Facts
Active ingredient

Pyrithione zinc 0.5%
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.
- apply to wet hair after shampooing by gently massaging into hair and scalp, rinse well.
Inactive ingredients

Water, stearyl alcohol, cetyl alcohol, stearamidopropyl dimethylamine, fragrance, dimethicone, glutamic acid, phenoxyethanol, benzyl alcohol, citric acid, sodium chloride, mentha piperita (peppermint) oil, menthol, mentha arvensis leaf oil, methylchloroisothiazolinone, methylisothiazolinone, yellow 5, blue 1.
Questions (or comments)?

1-800-723-9569
SPL UNCLASSIFIED SECTION

Dist. by PROCTER & GAMBLE,
CINCINNATI, OH 45202
PRINCIPAL DISPLAY PANEL - Kit Package

head &
shoulders ®

pyrithione zinc dandruff shampoo

smooth & silky

24 hour frizz control from root to tip

FLAKE FREE.*
UP TO 100%
COLOR SAFE

0.34 FL OZ (10 mL)

head &
shoulders ®

pyrithione zinc dandruff conditioner

smooth & silky

24 hour frizz control from root to tip

0.34 FL OZ (10 mL)

INGREDIENTS AND APPEARANCE

HEAD AND SHOULDERS DUAL SACHETS SMOOTH AND SILKY
pyrithione zinc kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69423-296

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69423-296-01	1 in 1 PACKAGE, COMBINATION	09/01/2018

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 POUCH	10 mL
Part 2	1 POUCH	10 mL

Part 1 of 2

HEAD AND SHOULDERS SMOOTH AND SILKY
pyrithione zinc lotion/shampoo

Product Information
Item Code (Source)	NDC:37000-094
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 100 mL

Ingredient Name	Strength
Inactive Ingredients
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
ZINC CARBONATE (UNII: EQR32Y7H0M)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
SODIUM XYLENESULFONATE (UNII: G4LZF950UR)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETYL ALCOHOL (UNII: 936JST6JCN)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BENZOATE (UNII: OJ245FE5EU)
MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)
BENZYL ALCOHOL (UNII: LKG8494WBH)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:37000-094-10	10 mL in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part358H	09/01/2013

Part 2 of 2

HEAD AND SHOULDERS CONDITIONER SMOOTH AND SILKY
pyrithione zinc lotion

Product Information
Item Code (Source)	NDC:69423-103
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	0.5 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
CETYL ALCOHOL (UNII: 936JST6JCN)
STEARAMIDOPROPYL DIMETHYLAMINE (UNII: K7VEI00UFR)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLUTAMIC ACID (UNII: 3KX376GY7L)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69423-103-10	10 mL in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part358H	11/10/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part358H	09/01/2018

Labeler - The Procter & Gamble Manufacturing Company (004238200)

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Published Date (What is this?)	Version	Files
Jan 10, 2020	2 (current)	download
Nov 16, 2018	1	download

	RxCUI	RxNorm NAME	RxTTY
1	209884	zinc pyrithione 1 % Medicated Shampoo	PSN
2	209884	zinc pyrithione 10 MG/ML Medicated Shampoo	SCD
3	209884	zinc pyrithione 1 % Medicated Conditioner	SY
4	209884	zinc pyrithione 1 % Medicated Shampoo	SY
5	1043014	zinc pyrithione 0.5 % Medicated Conditioner	PSN
6	1043014	zinc pyrithione 5 MG/ML Medicated Shampoo	SCD
7	1043014	zinc pyrithione 0.5 % Medicated Shampoo	SY
8	1043244	head & shoulders 1 % Medicated Shampoo	PSN
9	1043244	zinc pyrithione 10 MG/ML Medicated Shampoo [Head & Shoulders]	SBD
10	1043244	Head & Shoulders 10 MG/ML Medicated Shampoo	SY
11	1043244	Head & Shoulders 1 % Medicated Shampoo	SY
12	1044465	head & shoulders 0.5 % Medicated Shampoo	PSN
13	1044465	zinc pyrithione 5 MG/ML Medicated Shampoo [Head & Shoulders]	SBD
14	1044465	Head & Shoulders 0.5 % Conditioner	SY
15	1044465	Head & Shoulders 5 MG/ML Medicated Shampoo	SY
16	1441653	zinc pyrithione 1 % Medicated Shampoo (10 ML) / zinc pyrithione 0.5 % Medicated Conditioner (10 ML) Pack	PSN
17	1441653	{1 (10 ML) (zinc pyrithione 10 MG/ML Medicated Shampoo) / 1 (10 ML) (zinc pyrithione 5 MG/ML Medicated Shampoo) } Pack	GPCK
18	1441654	Head & Shoulders Dual Sachets Pack	PSN
19	1441654	{1 (10 ML) (zinc pyrithione 10 MG/ML Medicated Shampoo [Head & Shoulders]) / 1 (10 ML) (zinc pyrithione 5 MG/ML Medicated Shampoo [Head & Shoulders]) } Pack [Head & Shoulders Dual Sachets]	BPCK
20	1441654	Head & Shoulders Dual Sachets Pack	SY
21	1441654	Head & Shoulders Dual Sachets Pack (1 (0.34 FL OZ) (zinc pyrithione 1 % Medicated Shampoo [Head & Shoulders]) / 1 (0.34 FL OZ) (zinc pyrithione 0.5 % Medicated Conditioner [Head & Shoulders]))	SY

Label: HEAD AND SHOULDERS DUAL SACHETS SMOOTH AND SILKY- pyrithione zinc kit

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When using this product

Stop use and ask a doctor if

When using this product

Stop use and ask a doctor if

Find additional resources

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	NDC
1	37000-094-10
2	69423-103-10
3	69423-296-01 (inactivated)

Label: HEAD AND SHOULDERS DUAL SACHETS SMOOTH AND SILKY- pyrithione zinc kit

View Package Photos

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

When using this product

Stop use and ask a doctor if

When using this product

Stop use and ask a doctor if

Find additional resources

Safety

Related Resources

More Info on this Drug

HEAD AND SHOULDERS DUAL SACHETS SMOOTH AND SILKY- pyrithione zinc kit

Number of versions: 2

HEAD AND SHOULDERS DUAL SACHETS SMOOTH AND SILKY- pyrithione zinc kit

HEAD AND SHOULDERS DUAL SACHETS SMOOTH AND SILKY- pyrithione zinc kit

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HEAD AND SHOULDERS DUAL SACHETS SMOOTH AND SILKY- pyrithione zinc kit

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.