MOISTIE PURE ESSENCE- niacinamide liquid

United States - English - NLM (National Library of Medicine)

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Active ingredient:
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)
Available from:
Purecell Korea Co., Ltd.
INN (International Name):
NIACINAMIDE
Composition:
NIACINAMIDE 2 g in 100 mL
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Skin Protectant - Whitening Apply daily to your cleansed skin. Pure Essence can be attached to the Moistie Skin Therapy Steamer and used together with steam to make the skin clear and clean.
Authorization status:
unapproved drug other
Authorization number:
71609-0004-1

MOISTIE PURE ESSENCE- niacinamide liquid

Purecell 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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Drug Facts

Niacinamide

Water, Glycerin, Butylene Glycol

Skin Protectant - Whitening

keep out or reach of the children

Apply daily to your cleansed skin.

Pure Essence can be attached to the Moistie Skin Therapy Steamer and used together with steam to make

the skin clear and clean.

1. Do not use in the following cases(Eczema and scalp wounds)

2.Side Effects

1)Due to the use of this druf if rash, irritation, itching and symptopms of hypersnesitivity occur

dicontinue use and consult your phamacisr or doctor

3.General Precautions

1)If in contact with the eyes, wash out thoroughty with water If the symptoms are servere, seek medical

advice immediately

2)This product is for exeternal use only. Do not use for internal use

4.Storage and handling precautions

1)If possible, avoid direct sunlight and store in cool and area of low humidity

2)In order to maintain the quality of the product and avoid misuse

3)Avoid placing the product near fire and store out in reach of children

for external use only

MOISTIE PURE ESSENCE

niacinamide liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:716 0 9 -0 0 0 4

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

NIACINAMIDE (UNII: 25X51I8 RD4) (NIACINAMIDE - UNII:25X51I8 RD4)

NIACINAMIDE

2 g in 10 0 mL

Inactive Ingredients

Purecell Korea Co., Ltd.

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

GLYCERIN (UNII: PDC6 A3C0 OX)

BUTYLENE GLYCO L (UNII: 3XUS8 5K0 RA)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:716 0 9 -0 0 0 4-1

3 in 1 PACKAGE

0 6 /0 1/20 17

1

10 mL in 1 VIAL; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved drug o ther

0 6 /0 1/20 17

Labeler -

Purecell Korea Co., Ltd. (694667185)

Registrant -

Purecell Korea Co., Ltd. (694667185)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

BIO-FD&C. Co ., Ltd.

6 8 8 20 326 8

ma nufa c ture (716 0 9 -0 0 0 4)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Purecell Ko rea Co ., Ltd.

6 9 46 6 718 5

la be l(716 0 9 -0 0 0 4)

Revised: 8/2017

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