RAYDERM RE-GENERATING CREAM- glycerin cream cream
VORY MEDICAL. Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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

image description

RAYDERM RE-GENERATING CREAM
glycerin cream cream

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

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

Labeler - VORY MEDICAL. Inc (694721104)

Registrant - VORY MEDICAL. Inc (694721104)

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