FDA.reportPublic FDA data

Gentle Therapy

Manufacturer
SOLEO
Effective date
2017-08-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:12:32

Label at a glance#

ProductGentle Therapy
Active ingredientPYRITHIONE ZINC, PANTHENOL, NIACINAMIDE, BIOTIN
Label structure8 sections

Indications and uses

Helps prevent hair loss and strengthen hair root and thicken hair. Helps to treat symptoms caused by dandruff.

Dosage and administration

Wet hair and scalp with warm water, rub scalp with 3-5 ml and wait for 3 minutes or more thoroughly wash.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc pyrithione (2.1%)

Panthenol (0.5%)

Niacinamide (0.3%)

Biotin (0.06%)

Purpose

OTC - PURPOSE SECTION

Anti-dandruff

Hair tonic

Anti-hair loss

Uses

INDICATIONS & USAGE SECTION

Helps prevent hair loss and strengthen hair root and thicken hair. Helps to treat symptoms caused by dandruff.

Warnings

WARNINGS SECTION

For external use only

Do not use when scalp is red, inflamed, irritated, or painful

When using this product

- do not apply on other parts of the body

- avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water

- do not apply directly to wound or open cut

Stop use and ask a doctor if

- rash or irritation on skin develops and lasts

- condition does not improve or worsen after regular use of this product as directed

Keep out of reach of children section

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Wet hair and scalp with warm water, rub scalp with 3-5 ml and wait for 3 minutes or more thoroughly wash.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Sodium Laureth Sulfate, Ammonium Lauryl Sulfate, Cocamidopropyl Betaine, Glycerin, Polyquaternium-7, Dimethicone, Cocamide MEA, Sodium Benzoate, Cetrimonium Chloride, Phenoxyethanol, Fragrance, Guar Hydroxypropyltrimonium Chloride, Menthol, Carbomer, Zinc Chloride, Disodium EDTA, Sodium Chloride, Caramel, Salicylic Acid, Cocamide DEA, Citric acid, Sophora Flavescens Root Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Artemisia Princeps Extract, Coix Lacryma-Jobi Ma-yuen Seed Extract, Yeast Extract, Bifida Ferment Extract

Gentle Therapy Shampoo

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

gentle therapy shampoogentle therapy shampoo

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71693-100-022020-11-13C16284748780-19d75b9d0-e4f1-f424-e053-dadaa90a57ceGentle Therapy Shampoo
71693-100-022020-01-31C16284748780-19d75b9d0-e4f1-f424-e053-dadaa90a57ceGentle Therapy Shampoo

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71693-10071693-100-01, 71693-100-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AIACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
ZINC CHLORIDE86Q357L16BIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
SODIUM CHLORIDE451W47IQ8XIACT
CARAMELT9D99G2B1RIACT
SALICYLIC ACIDO414PZ4LPZIACT
COCO DIETHANOLAMIDE92005F972DIACT
COIX LACRYMA-JOBI VAR. MA-YUEN SEED8DW238I7ZIIACT
GLYCYRRHIZA GLABRA2788Z9758HIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB
PANTHENOLWV9CM0O67ZACTIB
NIACINAMIDE25X51I8RD4ACTIB
BIOTIN6SO6U10H04ACTIB
WATER059QF0KO0RIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
AMMONIUM LAURYL SULFATEQ7AO2R1M0BIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
GLYCERINPDC6A3C0OXIACT
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD)0L414VCS5YIACT
DIMETHICONE92RU3N3Y1OIACT
COCO MONOETHANOLAMIDEC80684146DIACT
SODIUM BENZOATEOJ245FE5EUIACT
CETRIMONIUM CHLORIDEUC9PE95IBPIACT
PHENOXYETHANOLHIE492ZZ3TIACT
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)B16G315W7AIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SOPHORA FLAVESCENS ROOTIYR6K8KQ5KIACT
YEAST, UNSPECIFIED3NY3SM6B8UIACT

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
b3f6d8fb-eaa3-1adb-e053-2a95a90a4e4b57d86ff8-2acf-80f1-e053-2a91aa0a83ae2020-11-12WarningsExact identifier
spl set id: 57d86ff8-2acf-80f1-e053-2a91aa0a83ae

Reported adverse events (FAERS/openFDA)#

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