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

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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

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