Label: RAYDERM RE-GENERATING CREAM- glycerin cream cream
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Contains inactivated NDC Code(s)
NDC Code(s): 72543-002-01 - Packager: VORY MEDICAL. Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated October 11, 2018
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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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
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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
- DOSAGE & ADMINISTRATION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
RAYDERM RE-GENERATING CREAM
glycerin cream creamProduct 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)