FDA.reportPublic FDA data

DESIGN ESSENTIALS PEPPERMINT - ALOE THERAPEUTICS

Manufacturer
.McBride Research Laboratories, Inc. | RNA PHARMA, LLC
Effective date
2016-01-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:44:55

Label at a glance#

ProductDESIGN ESSENTIALS PEPPERMINT - ALOE THERAPEUTICS
Active ingredientPYRITHIONE ZINC
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients:

Pyrithione Zinc 1%

OTC - PURPOSE SECTION

Purpose: Antidandruff

INDICATIONS & USAGE SECTION

Use: controls flaking, itching and irritation associated with dandruff and seborrheic dermatitis

WARNINGS SECTION

Warnings:

  • For external use only.

OTC - WHEN USING SECTION

When using this product Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

OTC - ASK DOCTOR SECTION

Consult your physician before using this product if condition covers a large area of the body.

OTC - STOP USE SECTION

Stop use and consult a physician if condition worsens or does not improve after regular use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

• For best results use at least twice a week or as directed by a physician.

• Wet hair, lather and massage gently into the hair and scalp.

• Rinse thoroughly and repeat if necessary.

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Water (Aqua), Sodium Lauryl Sulfate, Cocamidopropyl Betaine, Cocamidopropylamine Oxide, Propylene Glycol, Menthol, Mentha Piperita(Peppermint) Oil, Phenoxyethanol (and) DMDM Hydantoin (and) Iodopropnyl Butylcarbamate, Montmorillonite, Aloe Barbadensis (Aloe) Leaf Juice, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Guar Hydroxypropyltrimonium Chloride, Sodium Chloride, Citric Acid, FD& C Blue #1 (C.I. 420090), FD&C Red #33 (C.I. 17200), FD&C Yellow No.5 (C.I. 19140).

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


Mcbride Shampoo 8 ozMcbride Shampoo 8 oz

Mcbride Shampoo 32 ozMcbride Shampoo 32 oz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
209884zinc pyrithione 1 % Medicated ShampooPSN1
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD1
209884zinc pyrithione 1 % Medicated ConditionerSY1
209884zinc pyrithione 1 % Medicated ShampooSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69527-122-082020-01-31C16284748780-19d75b9d0-4ae6-f424-e053-dadaa90a57ceDESIGN ESSENTIALS PEPPERMINT & ALOE THERAPEUTICS ANTI-ITCH SHAMPOO
69527-122-322020-01-31C16284748780-19d75b9d0-4ae6-f424-e053-dadaa90a57ceDESIGN ESSENTIALS PEPPERMINT & ALOE THERAPEUTICS ANTI-ITCH SHAMPOO

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69527-122-08DESIGN ESSENTIALS PEPPERMINT - ALOE THERAPEUTICS237 mL in 1 BOTTLESHAMPOO2371
69527-122-32DESIGN ESSENTIALS PEPPERMINT - ALOE THERAPEUTICS947 mL in 1 BOTTLESHAMPOO9471

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69527-122DESIGN ESSENTIALS PEPPERMINT - ALOE THERAPEUTICS (PYRITHIONE ZINC) SHAMPOO [.MCBRIDE RESEARCH LABORATORIES, INC.]1Legacy NDC, 2 package rows20160208_346dbc17-ece0-46c5-8efb-2064dd0a560f.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69527-12269527-122-08, 69527-122-32

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
PYRITHIONE ZINCR953O2RHZ5ACTIB
WATER059QF0KO0RIACT
SODIUM LAURYL SULFATE368GB5141JIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
COCAMIDOPROPYLAMINE OXIDEM4SL82J7HKIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
MENTHOLL7T10EIP3AIACT
PEPPERMINT OILAV092KU4JHIACT
PHENOXYETHANOLHIE492ZZ3TIACT
DMDM HYDANTOINBYR0546TOWIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
MONTMORILLONITEA585MN1H2LIACT
ALOE VERA LEAFZY81Z83H0XIACT
TEA TREE OILVIF565UC2GIACT
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)B16G315W7AIACT
SODIUM CHLORIDE451W47IQ8XIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
D&C RED NO. 339DBA0SBB0LIACT
FD&C YELLOW NO. 5I753WB2F1MIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b5d7c9e5-d0dd-42a1-acc3-5e0f477a263a346dbc17-ece0-46c5-8efb-2064dd0a560f2016-01-20WarningsExact identifier
spl id: b5d7c9e5-d0dd-42a1-acc3-5e0f477a263a
spl set id: 346dbc17-ece0-46c5-8efb-2064dd0a560f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.