INTENSIVE TONE UP- niacinamide cream 
Racce 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: Niacinamide 2.0%

INACTIVE INGREDIENT

Inactive ingredients:

Water, Dipropylene Glycol, Glycerin, Cyclopentasiloxane, Dimethicone, Titanium Dioxide, 1,2-Hexanediol, C12-15 Alkyl Benzoate, Cetearyl Alcohol, Cyclohexasiloxane, Octyldodecanol, Malva Sylvestris (Mallow) Extract, Mentha Piperita (Peppermint) Leaf Extract, Primula Veris Extract, Alchemilla Vulgaris Extract, Veronica Officinalis Extract, Melissa Officinalis Leaf Extract, Achillea Millefolium Extract, Betaine, Kappaphycus Alvarezii Extract, Caesalpinia Spinosa Fruit Extract, Sodium Hyaluronate, Allantoin, Panthenol, Olea Europaea (Olive) Fruit Oil, Argania Spinosa Kernel Oil, Ethylhexylglycerin, Triethoxycaprylylsilane, Aluminum Hydroxide, Disodium EDTA, Cetearyl Olivate, Dipropylene Glycol Dibenzoate, Sorbitan Olivate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Sodium Polyacrylate, Dimethiconol, Phenoxyethanol, Cetyl PEG/PPG-10/1 Dimethicone, PPG-15 Stearyl Ether Benzoate, Ethanol, Sodium Hydroxide

PURPOSE

Purpose: Skin Brightening

WARNINGS

Warnings:

For external use only

Avoid contact with eyes: If contact or adverse reation occurs, rinse well and consult physician.

Keep out of the reach of children.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Uses

Uses:

It helps instantly brighten skin tone and maximize the moisturizing effect, improves dryness and dullness at the same time

Directions

Directions:

Gently apply onto cleansed face and neck

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

INTENSIVE TONE UP 
niacinamide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72092-080
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Niacinamide (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) Niacinamide1.00 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Dipropylene Glycol (UNII: E107L85C40)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72092-080-021 in 1 CARTON01/02/201812/01/2018
1NDC:72092-080-0150 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/02/201812/01/2018
Labeler - Racce Co., Ltd. (694890309)
Registrant - Racce Co., Ltd. (694890309)
Establishment
NameAddressID/FEIBusiness Operations
NEO-MEDICAL CO.,LTD689755531manufacture(72092-080)

Revised: 3/2019
 
Racce Co., Ltd.