Rayderm Re-generating Serum: Package Insert and Label Information

RAYDERM RE-GENERATING SERUM- glycerin lotion
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 (9.703%) — Skin Protectact

INACTIVE INGREDIENT

Purified Water, Propanediol, Pentylene Glycol, Caprylic/Capric Triglyceride, Rosehip Fruit Oil, Niacinamide, Black Rice Bran Extract, Butylene Glycol, rh-Polypeptide-1, rh-Oligopeptide-1, rh-Oligopeptide-2, rh-Polypeptide-62, rh-Polypeptide-3, Ceramide NP, Panthenol, Tocopheryl Acetate, Nelumbium Speciosum Flower Extract, Hydrolyzed Hyaluronic Acid, Pseudoalteromonas Fermented Extract, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Cetearyl Olivate, Sorbitan Olivate, Hydrogenated Lecithin, Adenosine, Sodium Hyaluronate, Caprylyl Glycol, 1,2-Hexanediol

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.

INDICATIONS & USAGE

Apply the cream on the skin and spread evenly.

DOSAGE & ADMINISTRATION

Apply the cream on the skin and spread evenly.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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RAYDERM RE-GENERATING SERUM
glycerin serum lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:72543-003
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
glycerin (GLYCERIN) glycerin 1.45 g in 15 mL
Inactive Ingredients
Ingredient Name Strength
water
PROPANEDIOL
GLYCERETH-26 CAPRYLATE
1,2-HEXANEDIOL
NIACINAMIDE
C14-22 ALCOHOLS
PANTHENOL
TREHALOSE
C12-20 ALKYL GLUCOSIDE
TROMETHAMINE
CERAMIDE NP
BUTYLENE GLYCOL
ETHYLHEXYLGLYCERIN
NELUMBO NUCIFERA FLOWER
ADENOSINE
CAPRYLYL GLYCOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72543-003-01 15 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 (72543-003)

Revised: 10/2018 VORY MEDICAL. Inc

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