VITAMIN B5- glycerin cream

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

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Active ingredient:
Glycerin (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)
Available from:
NATURE REPUBLIC CO., LTD.
INN (International Name):
Glycerin
Composition:
Glycerin 3.43 g in 50 mL
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Purpose: Skin Moisturizing Indications & Usage: The vitamin B5 cream helps moisturize and soothe dry and sensitive skin.
Authorization status:
unapproved drug other
Authorization number:
51346-437-01, 51346-437-02

VITAMIN B5- glycerin cream

NATURE REPUBLIC 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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ACTIVE INGREDIENT

Active ingredients: Glycerin 6.87%

INACTIVE INGREDIENT

Inactive ingredients: Water, Panthenol, Caprylic/Capric Triglyceride, Butylene Glycol,

Caprylic/Capric/Myristic/Stearic Triglyceride, Cetearyl Alcohol, Diisostearyl Malate, Dicaprylyl

Carbonate, Ethylhexyl Palmitate, Glyceryl Stearate SE, Macadamia Integrifolia Seed Oil, Polyglyceryl-

3 Methylglucose Distearate, Cocos Nucifera (Coconut) Oil, Pentylene Glycol, Butyrospermum Parkii

(Shea) Butter, Trehalose, Chondrus Crispus Extract, Dimethicone, Glyceryl Stearate, PEG-100

Stearate, Saccharum Officinarum (Sugarcane) Extract, Hydrogenated Lecithin, Sodium Acrylate/Sodium

Acryloyldimethyl Taurate Copolymer, Caprylyl Glycol, Isohexadecane, Citrus Aurantium Bergamia

(Bergamot) Fruit Oil, Carbomer, Ethylhexylglycerin, 1,2-Hexanediol, Tocopheryl Acetate, Polysorbate

80, Disodium EDTA, Tromethamine, Glyceryl Acrylate/Acrylic Acid Copolymer, Phenoxyethanol,

Sorbitan Oleate, Madecassoside

PURPOSE

Purpose: Skin Moisturizing

WARNINGS

Warnings: For external use only. Avoid contact with eyes and mouth. Discontinue use if signs of

irritation or rashes appear. Keep out of reach of children. Replace the cap after use.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

INDICATIONS & USAGE

Indications & Usage: The vitamin B5 cream helps moisturize and soothe dry and sensitive skin.

DOSAGE & ADMINISTRATION

Dosage & Administration: At the last step of basic skincare, apply an appropriate amount on the entire

face and gently pat to promote absorption.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VITAMIN B5

glycerin cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:51346 -437

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Glycerin (UNII: PDC6 A3C0 OX) (GLYCERIN - UNII:PDC6 A3C0 OX)

Glyc e rin

3.43 g in 50 mL

Inactive Ingredients

Ingredient Name

Stre ng th

NATURE REPUBLIC CO., LTD.

Wa ter (UNII: 0 59 QF0 KO0 R)

Pa ntheno l (UNII: WV9 CM0 O6 7Z)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:51346 -437-

1 in 1 CARTON

12/0 1/20 16

1

NDC:51346 -437-

50 mL in 1 BOTTLE, PUMP; Type 0 : No t a Co mbinatio n

Pro duc t

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

12/0 1/20 16

Labeler -

NAT URE REPUBLIC CO., LT D. (631172020)

Registrant -

NAT URE REPUBLIC CO., LT D. (631172020)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

NATURE REPUBLIC CO., LTD.

6 311720 20

re la be l(51346 -437)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Co smax, Inc

6 8 9 0 49 6 9 3

ma nufa c ture (51346 -437)

Revised: 1/2017

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