A.H.C.C-SERUM

Drug Labeling and Warnings

Drug Details [pdf]

A.H.C. C-SERUM- niacinamide cream 
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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A.H.C.
C-SERUM

ACTIVE INGREDIENT

ACTIVE INGREDIENT: Niacinamide 2%

• Active Ingredients: Purpose
• Niacinamide 2%: Skin Protectant

Uses

Help to improve skin brightness

Warning

For external use only

Do not use

on damage or broken skin

Keep out of reach of Children.

Apply small amount to a clean skin and massage gently with fingertips.

Dosage: Small Amount

Administration: apply to a clean skin and massage gently

Inactive Ingredients

WATER1,3-BUTYLENE GLYCOLDODECAMETHYLPENTASILOXANEGLYCERINHYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)POLYSORBATE 20MINERAL OILSQUALANECENTELLA ASIATICADIMETHICONEFICUS CARICA FLOWER BUDPORTULACA OLERACEA WHOLEPHENOXYETHANOLPIPER METHYSTICUM WHOLEMETHYLPARABENPOLYSORBATE 60.ALPHA.-TOCOPHEROL ACETATEPROPYLPARABENXANTHAN GUMMAGNESIUM DISODIUM EDTAHYDROGENATED SOYBEAN LECITHINCHOLESTEROLBASIC YELLOW 57N-ACETYLGLUCOSAMINEASCORBYL GLUCOSIDEAZELAMIDE MONOETHANOLAMINECERAMIDE 3PHYTOSPHINGOSINEHYALURONATE SODIUMTRIETHANOLAMINE HYDROCHLORIDETREHALOSEHYDROXYETHYL STARCH 130/0.4PANTHENOL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

A.H.C. C-SERUM 
niacinamide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58930-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	.6 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DODECAMETHYLPENTASILOXANE (UNII: 0QDQ2VQ5YJ)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
MINERAL OIL (UNII: T5L8T28FGP)
SQUALANE (UNII: GW89575KF9)
CENTELLA ASIATICA (UNII: 7M867G6T1U)
DIMETHICONE (UNII: 92RU3N3Y1O)
FICUS CARICA FLOWER BUD (UNII: 8I2PXY292P)
PORTULACA OLERACEA WHOLE (UNII: D5J3623SV2)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PIPER METHYSTICUM WHOLE (UNII: 3P306S300W)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 60 (UNII: CAL22UVI4M)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
XANTHAN GUM (UNII: TTV12P4NEE)
MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
CHOLESTEROL (UNII: 97C5T2UQ7J)
BASIC YELLOW 57 (UNII: 4N63359G0X)
N-ACETYLGLUCOSAMINE (UNII: V956696549)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
AZELAMIDE MONOETHANOLAMINE (UNII: U2NP04VHSG)
CERAMIDE 3 (UNII: 4370DF050B)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
TREHALOSE (UNII: B8WCK70T7I)
HYDROXYETHYL STARCH 130/0.4 (UNII: 1GVO236S58)
PANTHENOL (UNII: WV9CM0O67Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58930-011-02	1 in 1 CARTON	07/05/2013	12/01/2018
1	NDC: 58930-011-01	30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		07/05/2013	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(58930-011)

Revised: 5/2019

Document Id: 01c1b1e2-7ac9-4edf-a1bb-10bd397b9603

34390-5

Set id: 73061458-295d-45c3-a332-0893373d15e5

Version: 5

Effective Time: 20190516

 

Carver Korea Co.,Ltd