New Premium Notamo: Package Insert and Label Information

NEW PREMIUM NOTAMO- panthenol, niacinamide, menthol and salicylic acid shampoo
HELLO INTERNATIONAL

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.

Panthenol (0.5%)
Niacinamide (0.3%)
Menthol (0.07%)
Salicylic Acid (0.04%)

hair tonic antiseborrheic

Keep out of reach of children  Do not swallow. In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Uses Helps prevent hair loss and thicken hair. Keeps scalp clean, healthy and smooth.

Warnings
For external use only Do not use on damaged or broken scalp When using this product  Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. Stop use and ask doctor if rash or irritation on scalp develops and lasts.  Store at room temperature

Directions Wet your hair and scalp with timid water enough. Apply adequate amount on the palm of the hands, and massage scalp gently with the fingertips. Rinse with clean water.

Water, Sodium Laureth Sulfate, Ammonium lauryl Sulfate, Cocamidopropyl Betain, Zinc Pyrithione, Glycerin, Polyquaternium-7, Sodium Benzoate, Cocamide MEA, Phenoxyethanol, Fragrance, Guar Hydroxypropyltrimonium Chloride, Carbomer, Zinc Chloride, Disodium EDTA, Cetrimonium Chloride, Biotin, Sodium Chloride, Chrysanthemum Sibiricum Extract, Camellia Sinensis Leaf Extract, Camellia Japonica Seed Oil, Fragaria Chiloensis (Strawberry) Fruit Extract, Rosmarinus Officinalis (Rosemary) Extract, Macadamia Integrifolia Seed Oil, Morus Alba Bark Extract, Salvia Officinalis(Sage) Extract, Allantoin, Aloe Barbadensis Leaf Extract, Houttuynia Cordata Extract, Panax Ginseng Root Extract, Citrus Paradisi (Grapefruit) Fruit Extract, Perilla Frutescens Leaf Extract, Paeonia Lactiflora Root Extract, Acorus calamus root Extract, Cnidium Officinale Root Extract, Calendula Officinalis Flower Extract, Cocos Nucifera (Coconut) Oil, Hydrolyzed Silk, Hydrolyzed Collagen, Lawsonia Inermis (Henna) Extract, Equisetum Giganteum Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Citric Acid

New Premium Notamo Shampoo

NEW PREMIUM NOTAMO panthenol, niacinamide, menthol, salicylic acid shampoo

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69709-105 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Panthenol (PANTHENOL) Panthenol 0.005 in 500 mL Niacinamide (NIACINAMIDE) Niacinamide 0.003 in 500 mL Menthol (MENTHOL) Menthol 0.0007 in 500 mL Salicylic Acid (SALICYLIC ACID) Salicylic Acid 0.0004 in 500 mL

Inactive Ingredients Ingredient Name Strength water Sodium Laureth Sulfate Ammonium Lauryl Sulfate Cocamidopropyl Betaine PYRITHIONE ZINC Glycerin POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) Sodium Benzoate COCO MONOETHANOLAMIDE Phenoxyethanol GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) CARBOXYPOLYMETHYLENE Zinc Chloride EDETATE DISODIUM Cetrimonium Chloride Biotin Sodium Chloride GREEN TEA LEAF Camellia Japonica Seed Oil BEACH STRAWBERRY ROSEMARY MACADAMIA OIL MORUS ALBA BARK SALVIA OFFICINALIS ROOT Allantoin ALOE VERA LEAF HOUTTUYNIA CORDATA FLOWERING TOP ASIAN GINSENG GRAPEFRUIT PERILLA FRUTESCENS TOP PAEONIA LACTIFLORA ROOT ACORUS CALAMUS ROOT CNIDIUM OFFICINALE ROOT CALENDULA OFFICINALIS FLOWEr COCONUT OIL JOJOBA OIL CITRIC ACID MONOHYDRATE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:69709-105-02 1 BOTTLE in 1 PACKAGE contains a BOTTLE (69709-105-01) 1 NDC:69709-105-01 500 mL in 1 BOTTLE This package is contained within the PACKAGE (69709-105-02)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 04/27/2016

Labeler — HELLO INTERNATIONAL (689062090)

Registrant — HELLO INTERNATIONAL (689062090)

Establishment
Name	Address	ID/FEI	Operations
HELLO INTERNATIONAL		689062090	manufacture (69709-105)

Revised: 04/2016 HELLO INTERNATIONAL