AHC Phyto Complex Gel Ampoule

Drug Labeling and Warnings

Drug Details [pdf]

AHC PHYTO COMPLEX GEL AMPOULE- arbutin 2% liquid 
Carver Korea Co.,Ltd

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.

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AHC Phyto Complex Gel Ampoule

ACTIVE INGREDIENT

ACTIVE INGREDIENT

• Active Ingredients: Purpose
• Arbutin 2.0%: Skin Protectant

Uses

Helps to improve skin natural health

Warning

For external use only

do not use on damaged or broken skin

In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

 Apply to the entire face and gently pat the skin to enhance absorption

2-3 drops on your fingertips than apply to face

Inactive Ingredients

WATER
BUTYLENE GLYCOL
BIOSACCHARIDE GUM-1
GLYCERIN
CARBOMER 934
NATTOKINASE
TROLAMINE
METHYLPARABEN
PHENOXYETHANOL
SOY PROTEIN
POLYSORBATE 20
PORTULACA OLERACEA WHOLE
HYALURONATE SODIUM
FD&C YELLOW NO. 5
FD&C BLUE NO. 1

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AHC PHYTO COMPLEX GEL AMPOULE 
arbutin 2% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58930-041
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARBUTIN (UNII: C5INA23HXF) (ARBUTIN - UNII:C5INA23HXF)	ARBUTIN	0.6 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58930-041-01	1 in 1 CARTON	08/15/2013	12/01/2018
1		30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/15/2013	12/01/2018

Labeler - Carver Korea Co.,Ltd (688442290)

Registrant - Jemian USA Inc. (078822273)

Establishment
Name	Address	ID/FEI	Business Operations
HNG CO., LTD		689851457	manufacture(58930-041)

Revised: 5/2019

Document Id: d3d8027a-a1ea-4daf-88cd-64ad170c2186

34390-5

Set id: 66a41222-e687-4486-a6cc-71c15bceefb0

Version: 2

Effective Time: 20190517