Rayderm Hydrating Mask: Package Insert and Label Information

RAYDERM HYDRATING MASK- glycerin and allantoin liquid
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 (16%) — Skin Protectact

Allantoin (00.5%) — Skin Protectact

INACTIVE INGREDIENT

Purified Water, Dipropylene Glycol, PEG/PPG-17/6 Copolymer, Betaine, Butylene Glycol, 1,2-Hexanediol, Centella Asiatica Extract, Paeonia Suffruticosa Root Extract, Black Rice Bran Extract, Panthenol, Carbomer, Chamomilla Recutita (Matricaria) Flower Extract, PEG-60 Hydrogenated Castor Oil, Glyceryl Caprylate, Xanthan Gum, Potassium Hydroxide, Ethylhexylglycerin, Glyceryl Glucoside, Sodium Hyaluronate, Dipotassium Glycyrrhizate, Melaleuca Alternifolia (Tea Tree) Leaf Extract, Propolis Extract, Sambucus Nigra Flower Extract, Eucalyptus Globulus Leaf Extract, Pantolactone, Disodium EDTA, Fragrance

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
4. Avoid applying on the eye area
5. Use immediately after opening the package as the product may become dry, and do not reuse.
6. Be cautious if you have irritation on adhesive bandages and poultices.

KEEP OUT OF REACH OF CHILDREN

INDICATIONS & USAGE

1. After washing your face, apply toner to smooth uneven skin.Tear open the pouch at the top and pull out the sheet mask.
2. Unfold the mask and place it onto your face, aligning the holes with your eyes, nose and mouth.
3. Remove the sheet mask after relaxing for about 10 — 20 minutes.
4. Gently massage the leftover essence into your skin.

DOSAGE & ADMINISTRATION

1. After washing your face, apply toner to smooth uneven skin.Tear open the pouch at the top and pull out the sheet mask.
2. Unfold the mask and place it onto your face, aligning the holes with your eyes, nose and mouth.
3. Remove the sheet mask after relaxing for about 10 — 20 minutes.
4. Gently massage the leftover essence into your skin.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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RAYDERM HYDRATING MASK
glycerin mask liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:72543-001
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
glycerin (GLYCERIN) glycerin 3.84 g in 24 mL
ALLANTOIN (ALLANTOIN) ALLANTOIN 0.12 g in 24 mL
Inactive Ingredients
Ingredient Name Strength
water
DIPROPYLENE GLYCOL
PEG/PPG-17/6 COPOLYMER
BETAINE
BUTYLENE GLYCOL
1,2-HEXANEDIOL
CENTELLA ASIATICA
PAEONIA SUFFRUTICOSA ROOT
PANTHENOL
PEG-60 HYDROGENATED CASTOR OIL
GLYCERYL CAPRYLATE
XANTHAN GUM
POTASSIUM HYDROXIDE
ETHYLHEXYLGLYCERIN
MELALEUCA ALTERNIFOLIA LEAF
SAMBUCUS CANADENSIS FLOWER
EUCALYPTUS GLOBULUS LEAF
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72543-001-01 24 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 (72543-001)

Revised: 10/2018 VORY MEDICAL. Inc

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