Rayderm Re-generating Cream: Package Insert and Label Information

RAYDERM RE-GENERATING CREAM- glycerin 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.

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

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RAYDERM RE-GENERATING CREAM
glycerin cream cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:72543-002
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
glycerin (GLYCERIN) glycerin 12.5 g in 50 mL
Inactive Ingredients
Ingredient Name Strength
water
PROPANEDIOL
PENTYLENE GLYCOL
NIACINAMIDE
ROSA CANINA FRUIT OIL
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)
PANTHENOL
CETEARYL OLIVATE
SORBITAN OLIVATE
CERAMIDE NP
BUTYLENE GLYCOL
NELUMBO NUCIFERA FLOWER
ADENOSINE
1,2-HEXANEDIOL
CAPRYLYL GLYCOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72543-002-01 50 mL in 1 PACKAGE None
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 Operations
VORY MEDICAL. Inc 694721104 manufacture (72543-002)

Revised: 10/2018 VORY MEDICAL. Inc

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