CELLZYME AMPOULE- glycerin, eucalyptus oil, allantoin liquid
PHARMACAL-INTERNATIONAL. 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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Cellzyme Ampoule – Ampoule

Actvie Ingrdients

GLYCERIN (Skin protectant/7%)

EUCALYPTUS OIL (Skin protectant /0.1%)

ALLANTOIN (Skin protectant/0.03%)

Inactives

WATER,BUTYLENE GLYCOL, NIACINAMIDE, 1,2-HEXANEDIOL, GLYCOSYL TREHALOSE, HYDROGENATED STARCH, HYDROLYSATE, SODIUM HYALURONATE, GLYCERYL POLYACRYLATE, ALBUMEN EXTRACT, HYDROLYZED COLLAGEN, ALOE BARBADENSIS LEAF EXTRACT, BACILLUS/HOUTTUYNIA CORDATA EXTRACT FERMENT FILTRATE, PANAX GINSENG ROOT EXTRACT, SCUTELLARIA BAICALENSIS ROOT EXTRACT, MORUS ALBA BARK EXTRACT, CNIDIUM OFFICINALE ROOT EXTRACT, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, SOLANUM LYCOPERSICUM, (TOMATO) CALLUS CULTURE EXTRACT, NELUMBO NUCIFERA FLOWER EXTRACT, PORTULACA OLERACEA EXTRACT, ADENOSINE, HYDROXYETHYLCELLULOSE, CARBOMER, TROMETHAMINE, PEG-60 HYDROGENATED CASTOR OIL, DISODIUM EDTA, FRAGRANCE

Purpose

Skin Protectant

Indication and Usage

Protect the skin. Helps wrinkle improvement and skin whitening.

Dosage and Administration

Apply smoothly on the entire face in the morning and night

Warnings

If following symptoms occur, stop use and consult a doctor: red spots, swelling, itching, irritation, or symptoms on applied skin under direct sunlight. Do not use on scarred skin, or if you have dermatitis or eczema. Keep away from direct sunlight or heat. Keep out of reach of children.

Keep out of reach of children

Product Labels

image description

CELLZYME AMPOULE
glycerin, eucalyptus oil, allantoin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:24765-110
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	9.1 g in 100 mL
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662)	EUCALYPTUS OIL	0.092 g in 100 mL
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	0.043 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
NIACINAMIDE (UNII: 25X51I8RD4)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
BEMISIOSE (UNII: 76B4LOB2YC)
HYDROGENATED STARCH HYDROLYSATE (UNII: 27F77DSJ5V)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
EGG WHITE (UNII: 3E0I92Z2GR)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22)
ASIAN GINSENG (UNII: CUQ3A77YXI)
MORUS ALBA BARK (UNII: 7O71A48NDP)
CNIDIUM OFFICINALE ROOT (UNII: 8S3OZD358J)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
TOMATO (UNII: Z4KHF2C175)
NELUMBO NUCIFERA FLOWER (UNII: 61W322NLDV)
PURSLANE (UNII: M6S840WXG5)
ADENOSINE (UNII: K72T3FS567)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
TROMETHAMINE (UNII: 023C2WHX2V)
PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:24765-110-01	5 mL in 1 AMPULE; Type 0: Not a Combination Product	09/14/2017	05/20/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	08/16/2017	05/20/2021

Labeler - PHARMACAL-INTERNATIONAL. CO., LTD (557805060)

Name	Address	ID/FEI	Business Operations
Establishment
GreenCos Co., Ltd		694777325	manufacture(24765-110)

Revised: 5/2021

Document Id: c3568f58-9cb9-a52a-e053-2a95a90a66aa

Set id: 29d335cb-33bf-441d-aa75-5c7eb2b5344c

Version: 4

Effective Time: 20210527

PHARMACAL-INTERNATIONAL. CO., LTD