FDA.reportPublic FDA data

Head and Shoulders

Manufacturer
ALL NATURAL DYNAMICS | Procter & Gamble Manufactura, S. de R.L. de C.V.
Effective date
2013-01-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:34:22

Key Label Information#

Active Ingredients And Purpose

Active ingredient

Pyrithione zinc 1%

Uses

Uses

helps prevent recurrence of flaking and itching associated with dandruff.

Warnings

Warnings

For external use only.

Directions And Dosage

Directions

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.

Other Label Information

Inactive ingredients

Water, sodium laureth sulfate, sodium lauryl sulfate, cocamide MEA, zinc carbonate, glycol distearate, dimethicone, fragrance, guar hydroxypropyltrimonium chloride, magnesium sulfate, sodium benzoate, magnesium carbonate hydroxide, ammonium laureth sulfate, sodium chloride, methylchloroisothiazolinone, methylisothiazolinone, sodium xylenesulfonate, blue 1, D&C red 33.

Questions (or comments)?

01-800-717-2413

Label Images#

renew
renew

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043244head & shoulders 1 % Medicated ShampooPSN1
209884zinc pyrithione 1 % Medicated ShampooPSN1
1043244zinc pyrithione 10 MG/ML Medicated Shampoo [Head & Shoulders]SBD1
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD1
1043244Head & Shoulders 1 % Medicated ShampooSY1
1043244Head & Shoulders 10 MG/ML Medicated ShampooSY1
209884zinc pyrithione 1 % Medicated ConditionerSY1
209884zinc pyrithione 1 % Medicated ShampooSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51769-139-012019-11-27C16284748780-19855d018-e08d-cd31-e053-dbdaa90ab51aHead and Shoulders renewing clean
51769-139-052019-11-27C16284748780-19855d018-e08d-cd31-e053-dbdaa90ab51aHead and Shoulders renewing clean
51769-139-112019-11-27C16284748780-19855d018-e08d-cd31-e053-dbdaa90ab51aHead and Shoulders renewing clean
51769-139-182019-11-27C16284748780-19855d018-e08d-cd31-e053-dbdaa90ab51aHead and Shoulders renewing clean
51769-139-202019-11-27C16284748780-19855d018-e08d-cd31-e053-dbdaa90ab51aHead and Shoulders renewing clean
51769-139-402019-11-27C16284748780-19855d018-e08d-cd31-e053-dbdaa90ab51aHead and Shoulders renewing clean
51769-139-502019-11-27C16284748780-19855d018-e08d-cd31-e053-dbdaa90ab51aHead and Shoulders renewing clean
51769-139-702019-11-27C16284748780-19855d018-e08d-cd31-e053-dbdaa90ab51aHead and Shoulders renewing clean

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51769-139-01Head and Shouldersrenewing clean10 mL in 1 POUCHLOTION/SHAMPOO101
51769-139-05Head and Shouldersrenewing clean50 mL in 1 BOTTLE, PLASTICLOTION/SHAMPOO501
51769-139-11Head and Shouldersrenewing clean1000 mL in 1 BOTTLE, PLASTICLOTION/SHAMPOO10001
51769-139-18Head and Shouldersrenewing clean1180 mL in 1 BOTTLE, PLASTICLOTION/SHAMPOO11801
51769-139-20Head and Shouldersrenewing clean200 mL in 1 BOTTLE, PLASTICLOTION/SHAMPOO2001
51769-139-40Head and Shouldersrenewing clean400 mL in 1 BOTTLE, PLASTICLOTION/SHAMPOO4001
51769-139-50Head and Shouldersrenewing clean500 mL in 1 BOTTLE, PLASTICLOTION/SHAMPOO5001
51769-139-70Head and Shouldersrenewing clean700 mL in 1 BOTTLE, PLASTICLOTION/SHAMPOO7001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51769-139HEAD AND SHOULDERS RENEWING CLEAN (PYRITHIONE ZINC) LOTION/SHAMPOO [ALL NATURAL DYNAMICS]1Legacy NDC, 8 package rows20130130_d5d3eea1-e97d-4d63-9329-35e38ece507a.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Pyrithione ZincACTIVE INGREDIENTR953O2RHZ51
PYRITHIONE ZINCACTIVE MOIETYR953O2RHZ51
Coco MonoethanolamideINACTIVE INGREDIENTC80684146D1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0L1
dimethiconeINACTIVE INGREDIENT92RU3N3Y1O1
FD&C blue no. 1INACTIVE INGREDIENTH3R47K3TBD1
glycol distearateINACTIVE INGREDIENT13W7MDN21W1
guar hydroxypropyltrimonium chloride (1.7 substituents per saccharide)INACTIVE INGREDIENTB16G315W7A1
magnesium carbonate hydroxideINACTIVE INGREDIENTYQO029V1L41
magnesium sulfateINACTIVE INGREDIENTDE08037SAB1
methylchloroisothiazolinoneINACTIVE INGREDIENTDEL7T5QRPN1
methylisothiazolinoneINACTIVE INGREDIENT229D0E1QFA1
sodium benzoateINACTIVE INGREDIENTOJ245FE5EU1
sodium chlorideINACTIVE INGREDIENT451W47IQ8X1
sodium laureth sulfateINACTIVE INGREDIENTBPV390UAP01
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141J1
sodium xylenesulfonateINACTIVE INGREDIENTG4LZF950UR1
WaterINACTIVE INGREDIENT059QF0KO0R1
zinc carbonateINACTIVE INGREDIENTEQR32Y7H0M1

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51769-13951769-139-40, 51769-139-50, 51769-139-20, 51769-139-70, 51769-139-11, 51769-139-18, 51769-139-05, 51769-139-01

Ingredients#

Name, UNII, Kind table
NameUNIIKind
Pyrithione ZincR953O2RHZ5ACTIB
Water059QF0KO0RIACT
sodium laureth sulfateBPV390UAP0IACT
sodium lauryl sulfate368GB5141JIACT
Coco MonoethanolamideC80684146DIACT
zinc carbonateEQR32Y7H0MIACT
glycol distearate13W7MDN21WIACT
dimethicone92RU3N3Y1OIACT
guar hydroxypropyltrimonium chloride (1.7 substituents per saccharide)B16G315W7AIACT
magnesium sulfateDE08037SABIACT
sodium benzoateOJ245FE5EUIACT
magnesium carbonate hydroxideYQO029V1L4IACT
sodium chloride451W47IQ8XIACT
methylchloroisothiazolinoneDEL7T5QRPNIACT
methylisothiazolinone229D0E1QFAIACT
sodium xylenesulfonateG4LZF950URIACT
FD&C blue no. 1H3R47K3TBDIACT
D&C RED NO. 339DBA0SBB0LIACT

Complete SPL Sections#

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Pyrithione zinc 1%

Uses

INDICATIONS & USAGE SECTION

helps prevent recurrence of flaking and itching associated with dandruff.

Warnings

WARNINGS SECTION

For external use only.

Directions

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

Water, sodium laureth sulfate, sodium lauryl sulfate, cocamide MEA, zinc carbonate, glycol distearate, dimethicone, fragrance, guar hydroxypropyltrimonium chloride, magnesium sulfate, sodium benzoate, magnesium carbonate hydroxide, ammonium laureth sulfate, sodium chloride, methylchloroisothiazolinone, methylisothiazolinone, sodium xylenesulfonate, blue 1, D&C red 33.

Questions (or comments)?

OTC - QUESTIONS SECTION

01-800-717-2413

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Dist. by Procter & Gamble Manufactura, S. de R.L. de C.V. San Andr`s Atoto No. 326, Naucalpan de Juarez, Estado de Mexico, MX www.headandshoulders.com

Source Document#

Source XML