BIOXIDEA MIRACLE 48 EXCELLENCE GOLD MASK- allantoin gel
Cosmetics Institute Technology Co., Ltd.

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

Active ingredient: Allantoin 0.5%

INACTIVE INGREDIENT

Inactive ingredients:
Aqua/Water/Eau, Aloe Barbadensis Leaf Extract, Glycerin, Dipropylene Glycol, Citrus Unshiu Peel Extract, Butylene Glycol, Niacinamide, Algae Extract, Camellia Sinensis Leaf Extract, Chondrus Crispus (Carrageenan), Ceratonia Siliqua Gum, Cyamopsis Tetragonoloba (Guar) Gum, Glucose, Glycine Soja Phytoplacenta Extract, Colloidal Gold, Acetyl Hexapeptide-8, Potassium Chloride, Rose Extract, 1,2-Hexanediol, Ubiquinone, Pearl Powder, Collagen, Tocopheryl Acetate, Rosa Centifolia Flower Water, Punica Granatum Fruit Extract, Lactobacillus/Aloe Barbadensis Ferment Filtrate, Disodium EDTA, Adenosine, Snail Secretion Filtrate, Mica, Chamomilla Recutita (Matricaria) Extract, Fragrance/Parfum

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warnings: For external use only.

KEEP OUT OF REACH OF CHILDREN

INDICATIONS & USAGE

Indications and Usage: After cleansing, place mask on your face. Leave it on for 20-30 minutes. Gently remove the mask and lightly massage any remaining serum into your skin. Do not rinse.

DOSAGE & ADMINISTRATION

Dosage and Administration: Use at least twice a week.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

BIOXIDEA MIRACLE 48 EXCELLENCE GOLD MASK
allantoin gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69133-020
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	Allantoin	0.15 g in 3

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69133-020-01	3 in 1 CARTON

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	07/01/2014

Labeler - Cosmetics Institute Technology Co., Ltd. (690081646)

Registrant - Cosmetics Institute Technology Co., Ltd. (690081646)

Name	Address	ID/FEI	Business Operations
Establishment
Cosmetics Institute Technology Co., Ltd.		690081646	manufacture(69133-020)