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Gentle Therapy

Dosage form: shampoo
Ingredients: PYRITHIONE ZINC 15.75g in 750mL, PANTHENOL 3.75g in 750mL, NIACINAMIDE 2.25g in 750mL, BIOTIN 0.45g in 750mL
Labeler: SOLEO
NDC Code: 71693-100

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Gentle Therapy Shampoo

Active ingredients

Zinc pyrithione (2.1%)

Panthenol (0.5%)

Niacinamide (0.3%)

Biotin (0.06%)

Purpose

Anti-dandruff

Hair tonic

Anti-hair loss

Uses

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

Warnings

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

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

Directions

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

Inactive ingredients

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

GENTLE THERAPY 
zinc pyrithione, panthenol, niacinamide, biotin shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71693-100
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (PYRITHIONE ZINC) PYRITHIONE ZINC15.75 g  in 750 mL
PANTHENOL (PANTHENOL) PANTHENOL3.75 g  in 750 mL
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE2.25 g  in 750 mL
BIOTIN (BIOTIN) BIOTIN0.45 g  in 750 mL
Inactive Ingredients
Ingredient NameStrength
MENTHOL 
CARBOXYPOLYMETHYLENE 
ZINC CHLORIDE 
EDETATE DISODIUM ANHYDROUS 
SODIUM CHLORIDE 
CARAMEL 
SALICYLIC ACID 
COCO DIETHANOLAMIDE 
COIX LACRYMA-JOBI VAR. MA-YUEN SEED 
GLYCYRRHIZA GLABRA 
WATER 
SODIUM LAURETH SULFATE 
AMMONIUM LAURYL SULFATE 
COCAMIDOPROPYL BETAINE 
GLYCERIN 
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) 
DIMETHICONE 
COCO MONOETHANOLAMIDE 
SODIUM BENZOATE 
CETRIMONIUM CHLORIDE 
PHENOXYETHANOL 
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) 
CITRIC ACID MONOHYDRATE 
SOPHORA FLAVESCENS ROOT 
YEAST, UNSPECIFIED 
Packaging
#Item CodePackage Description
1NDC:71693-100-021 BOTTLE in 1 PACKAGE
1NDC:71693-100-01750 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/28/2017
Labeler - SOLEO (557829412)
Registrant - SOLEO (557829412)
Establishment
NameAddressID/FEIOperations
SOLEO557829412manufacture(71693-100)

Revised: 08/2017
 
SOLEO

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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