GENTLE THERAPY- zinc pyrithione, panthenol, niacinamide, biotin shampoo

Gentle Therapy by

Drug Labeling and Warnings

Gentle Therapy by is a Otc medication manufactured, distributed, or labeled by SOLEO. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

GENTLE THERAPY 
zinc pyrithione, panthenol, niacinamide, biotin shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71693-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	15.75 g  in 750 mL
PANTHENOL (UNII: WV9CM0O67Z) (PANTHENOL - UNII:WV9CM0O67Z)	PANTHENOL	3.75 g  in 750 mL
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	2.25 g  in 750 mL
BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04)	BIOTIN	0.45 g  in 750 mL

Inactive Ingredients
Ingredient Name	Strength
MENTHOL (UNII: L7T10EIP3A)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
ZINC CHLORIDE (UNII: 86Q357L16B)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CARAMEL (UNII: T9D99G2B1R)
SALICYLIC ACID (UNII: O414PZ4LPZ)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
COIX LACRYMA-JOBI VAR. MA-YUEN SEED (UNII: 8DW238I7ZI)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
GLYCERIN (UNII: PDC6A3C0OX)
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)
DIMETHICONE (UNII: 92RU3N3Y1O)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71693-100-02	1 in 1 PACKAGE	08/28/2017
1	NDC: 71693-100-01	750 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/28/2017

Labeler - SOLEO (557829412)

Registrant - SOLEO (557829412)

Establishment
Name	Address	ID/FEI	Business Operations
SOLEO		557829412	manufacture(71693-100)