RAYDERM RE-GENERATING CREAM- glycerin cream cream

Rayderm Re-generating Cream by

Drug Labeling and Warnings

Rayderm Re-generating Cream by is a Otc medication manufactured, distributed, or labeled by VORY MEDICAL. Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Glycerin (25.003%) - 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.
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 cream on the skin and spread evenly.

DOSAGE & ADMINISTRATION

Apply the cream on the skin and spread evenly.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RAYDERM RE-GENERATING CREAM 
glycerin cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72543-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
glycerin (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	glycerin	12.5 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
PROPANEDIOL (UNII: 5965N8W85T)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
NIACINAMIDE (UNII: 25X51I8RD4)
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
PANTHENOL (UNII: WV9CM0O67Z)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
SORBITAN OLIVATE (UNII: MDL271E3GR)
CERAMIDE NP (UNII: 4370DF050B)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
NELUMBO NUCIFERA FLOWER (UNII: 61W322NLDV)
ADENOSINE (UNII: K72T3FS567)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72543-002-01	50 mL in 1 PACKAGE; Type 0: Not a Combination Product	10/11/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	10/11/2018

Labeler - VORY MEDICAL. Inc (694721104)

Registrant - VORY MEDICAL. Inc (694721104)

Establishment
Name	Address	ID/FEI	Business Operations
VORY MEDICAL. Inc		694721104	manufacture(72543-002)