IDENEL LIGHT R TOX DAILY- niacinamide, panthenol, dimethicone cream 
SR biotek Inc.

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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IDENEL Light R-Tox Daily Cream

Niacinamide (2%)
Dimethicone (1%)
Panthenol (1%)

skin protectant

Keep out of reach of children
 Do not swallow. In case of accidental ingestion, seek professional assistance.

Moisturizes skin. Keep skin soft and smooth and helps to improve skin elasticity.

For external use only
Do not use when Your skin is red, inflamed, irritated or painful
When using this product
 Do not apply on other parts of the body
 Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
 Do not apply directly to wound or open cut.
Stop use and ask doctor if rash or irritation on skin develops and lasts.
Store at room temperature

Directions
Apply the amount of pearl size using enclosed spatula onto skin evenly until it is absorbed at the final step before make up.

Water, Glycerin, Cetearyl Alcohol, Cetearyl Glucoside, Sorbitan Olivate, Butylene Glycol, Macadamia Integrifolia Seed Oil, Stearic Acid, Centella Asiatica Extract, Polyglutamic acid, Methionine, Serine, Histidine, 1,2-Hexanediol, Hydroxyethyl Ethylcellulose, Bacopa Monniera Extract, Hydroxyethylcellulose, Orbignya Oleifera Seed Oil, Carthamus Tinctorius (Safflower) Seed Oil, Sodium Hyaluronate, Squalane, Caprylic/Capric Triglyceride, Cetyl Ethylhexanoate, Paeonia Suffruticosa Root Extract, Belamcanda Chinensis Root Extract, Lecithin, Acetyl Glutamine, Caprylyl glycol, Hydrolyzed Corn Protein, Hydrolyzed Wheat Protein, Hydrolyzed Soy Protein, Hydrolyzed Silk, Beeswax, Octanediol, Ethylhexylglycerin, Citrus grandis (grapefruit) seed extract, Artemisia princeps leaf extract, Polygonum Cuspidatum Root Extract, Scutellaria Baicalensis Root Extract, Camellia Sinensis Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Chamomilla Recutita (matricaria) Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Portulaca Oleracea Extract, Allantoin, Dipotassium Glycyrrhizate, Tocopheryl Acetate, Silica, Carbomer, Triethanolamine, Disodium EDTA

IDENEL Light R-Tox Daily Cream

r tox daily cream

IDENEL LIGHT R TOX DAILY 
niacinamide, panthenol, dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70198-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE0.02   in 50 mL
PANTHENOL (UNII: WV9CM0O67Z) (PANTHENOL - UNII:WV9CM0O67Z) PANTHENOL0.01   in 50 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.01   in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
MACADAMIA OIL (UNII: 515610SU8C)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CENTELLA ASIATICA (UNII: 7M867G6T1U)  
METHIONINE (UNII: AE28F7PNPL)  
SERINE (UNII: 452VLY9402)  
HISTIDINE (UNII: 4QD397987E)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
HYDROXYETHYL ETHYLCELLULOSE (UNII: ZDN57Z154K)  
HYDROXYETHYL CELLULOSE (6500 MPA.S AT 2%) (UNII: 2Q40985DRM)  
BABASSU OIL (UNII: 8QSB4M5477)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
SQUALANE (UNII: GW89575KF9)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)  
PAEONIA SUFFRUTICOSA ROOT (UNII: 7M7E9A2C8J)  
IRIS DOMESTICA ROOT (UNII: T2MU9QFA87)  
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
ACEGLUTAMIDE (UNII: 01J18G9G97)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
OCTANEDIOL (UNII: 806K32R50Z)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
CITRUS MAXIMA SEED (UNII: 083X55C543)  
ARTEMISIA PRINCEPS LEAF (UNII: SY077EW02G)  
POLYGONUM CUSPIDATUM ROOT (UNII: 7TRV45YZF7)  
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
CHAMOMILE (UNII: FGL3685T2X)  
ROSEMARY (UNII: IJ67X351P9)  
PURSLANE (UNII: M6S840WXG5)  
ALLANTOIN (UNII: 344S277G0Z)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ADENOSINE (UNII: K72T3FS567)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)  
TROLAMINE (UNII: 9O3K93S3TK)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70198-101-021 in 1 BOX11/12/201512/31/2016
1NDC:70198-101-0150 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other11/12/201512/31/2016
Labeler - SR biotek Inc. (557830376)
Registrant - SR biotek Inc. (557830376)
Establishment
NameAddressID/FEIBusiness Operations
SR biotek Inc.557830376manufacture(70198-101)

Revised: 6/2019
Document Id: 8bcc4350-ab2e-510f-e053-2995a90a9166
Set id: b367fa8c-a3a3-47ca-8b0e-fbb4db1a91b1
Version: 4
Effective Time: 20190620
 
SR biotek Inc.