Rayderm Hydrating Toner: Package Insert and Label Information

RAYDERM HYDRATING TONER- glycerin liquid
VORY MEDICAL. Inc

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.

ACTIVE INGREDIENT

Glycerin (2.5%) — Skin Protectact

INACTIVE INGREDIENT

Purified Water, Propanediol, Dipropylene, Methyl Gluceth-20, Glycereth-26, Glycerin, Pentylene Glycol, Betaine, C12-14 Pareth-12, Trehalose, Salvia Hispanica Seed Extract, Centella Asiatica Extract, Houttuynia Cordata Extract, Polyquaternium-51, Sodium Citrate, Sea Buckthorn Water, Butylene Glycol, Ethylhexylglycerin, 1,2-Hexanediol, Citric Acid, Sodium Palmitoyl Proline, Nymphaea Tetragona Flower Extract, Green tea Extract, Black Rice Bran Extract, Cucumber Extract, Caprylyl Glycol, Fragrance

PURPOSE

Skin Protectact

WARNINGS

Precautions of Use
1) If rash, redness, swelling, itching or other adverse reactions occur as a result of exposure to sunlight during or after use, consult a doctor / specialist.
2) Refrain from using on wound sites.
3) Storage and handling precautions:
i) Keep out of reach of children.
ii) Keep away from direct sunlight

KEEP OUT OF REACH OF CHILDREN

INDICATIONS & USAGE

Apply the toner on the skin and spread evenly.

DOSAGE & ADMINISTRATION

Apply the toner on the skin and spread evenly.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RAYDERM HYDRATING TONER glycerin toner liquid

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72543-004 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength glycerin (GLYCERIN) glycerin 6.25 g in 250 mL

Inactive Ingredients Ingredient Name Strength water PROPANEDIOL DIPROPYLENE GLYCOL METHYL GLUCETH-20 GLYCERETH-26 PENTYLENE GLYCOL BETAINE C12-14 PARETH-12 TREHALOSE SALVIA HISPANICA SEED CENTELLA ASIATICA POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) SODIUM CITRATE BUTYLENE GLYCOL ETHYLHEXYLGLYCERIN 1,2-HEXANEDIOL SODIUM PALMITOYL PROLINE NYMPHAEA ALBA FLOWER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:72543-004-01 250 mL in 1 PACKAGE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 10/11/2018

Labeler — VORY MEDICAL. Inc (694721104)

Registrant — VORY MEDICAL. Inc (694721104)

Establishment
Name	Address	ID/FEI	Operations
VORY MEDICAL. Inc		694721104	manufacture (72543-004)

Revised: 10/2018 VORY MEDICAL. Inc