Phytopecia Hair Tonic: Package Insert and Label Information

PHYTOPECIA HAIR TONIC- panthenol, niacinamide and biotin liquid
Phytos Co., Ltd.

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 (1%) Niacinamide (0.5%) Biotin (0.01%)

Hair tonic

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.

Keeps scalp feed essential nutrients. Helps scalp maintenance healthy and elastic hair.

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 1. After shampoo, spray 1-2 times on desired area on dry scalp and gently massage with the fingertips. 2. Use 1-2 times a day. Continuous use at least for 3 months. 3. No tangling hair and unpleasant smell, so you can use before you go outside. 4. Do not spray on hair.

Water, Alcohol Denat., Dimethyl Sulfone, 1,2-Hexanediol, Copper Tripeptide-1, Lecithin, Camellia Sinensis Leaf Extract, Human Oligopeptide-1, rh-Oligopeptide-2, rh-Polypeptide-1, rh-Polypeptide-9, rh-Polypeptide-11, Dipotassium Glycyrrhizate, Polysorbate 80, Menthol, Chamomilla Recutita (Matricaria) Flower Extract, Morus Alba Bark Extract, Rosmarinus Officinalis (Rosemary) Extract, Tocopheryl Acetate, Poloxamer 407, Glucosyl Hesperidin,Salicylic Acid, Phytosphingosine Phosphate

Phytopecia Hair Tonic

PHYTOPECIA HAIR TONIC panthenol, niacinamide, salicylic acid liquid

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69579-106 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Panthenol (PANTHENOL) Panthenol 0.01 in 60 mL Niacinamide (NIACINAMIDE) Niacinamide 0.005 in 60 mL biotin (BIOTIN) biotin 0.0001 in 60 mL

Inactive Ingredients Ingredient Name Strength water ALCOHOL DIMETHYL SULFONE 1,2-Hexanediol PREZATIDE COPPER EGG PHOSPHOLIPIDS GREEN TEA LEAF MECASERMIN BASIC FIBROBLAST GROWTH FACTOR (HUMAN) FIBROBLAST GROWTH FACTOR-1 GLYCYRRHIZINATE DIPOTASSIUM Polysorbate 80 Menthol CHAMOMILE MORUS ALBA BARK ROSEMARY .ALPHA.-TOCOPHEROL ACETATE Poloxamer 407 Glucosyl Hesperidin Salicylic Acid

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:69579-106-02 1 BOTTLE, SPRAY in 1 BOX contains a BOTTLE, SPRAY (69579-106-01) 1 NDC:69579-106-01 60 mL in 1 BOTTLE, SPRAY This package is contained within the BOX (69579-106-02)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 12/18/2015

Labeler — Phytos Co., Ltd. (689196775)

Registrant — Phytos Co., Ltd. (689196775)

Establishment
Name	Address	ID/FEI	Operations
Phytos Co., Ltd.		689196775	manufacture (69579-106)

Revised: 12/2015 Phytos Co., Ltd.