Mineral Homme White Toner by The Saem International Co., Ltd.

Mineral Homme White Toner by

Drug Labeling and Warnings

Mineral Homme White Toner by is a Otc medication manufactured, distributed, or labeled by The Saem International Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MINERAL HOMME WHITE TONER- niacinamide liquid 
The Saem International 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, Alcohol Denat., Dipropylene Glycol, Pentylene Glycol, PEG-60 Hydrogenated Castor Oil, Betaine, Saccharum Officinarum (Sugar Cane) Extract, Chondrus Crispus Extract, Phenoxyethanol, Fragrance(Parfum), Octyldodeceth-16, Panthenol, Diethoxyethyl Succinate, Butylene Glycol, Disodium EDTA, Carbomer, Tromethamine, Quartz, Pearl Powder, Glycerin, Ethylhexylglycerin, Pseudoalteromonas Ferment Extract, Xanthan Gum, Caprylyl Glycol, Sodium Polyacrylate, Hedera Helix (Ivy) Leaf/Stem Extract, Serine, Alanine, Phytic Acid, Proline, PEG-8, PPG-1-PEG-9 Lauryl Glycol Ether, Helianthus Annuus (Sunflower) Seed Extract, Sodium Phosphate, Sodium Hydroxide, Phytosphingosine, Aqua, Magnesium Aspartate, Zinc Gluconate, Copper Gluconate, Diamond powder

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warning: 1. In case of having following symptoms after using this, you're advised to stop using it immediately. If you keep using it, the symptoms will get worse and need to consult a dermatologist. 1) In case of having problems such as red rash, swollenness, itching, stimulation during usage. 2) In case of having the same symptoms above on the part you put this product on by direct sunlight. 2. You are banned to use it on the part where you have a scar, eczema, or dermatitis. 3. In case of getting it into your eyes, you have to wash it immediately.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of Children: Keep out of reach of babies and children

INDICATIONS & USAGE

Indication & Usage: After cleansing or shaving, dispense a small amount into palms and gently pat into skin

DOSAGE & ADMINISTRATION

Dosage & Administration: Take an adequate amount of this product.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

MINERAL HOMME WHITE TONER 
niacinamide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70341-020
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Niacinamide (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) Niacinamide2.6 g  in 130 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Dipropylene Glycol (UNII: E107L85C40)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70341-020-01130 mL in 1 CARTON; Type 0: Not a Combination Product12/01/201511/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/01/201511/01/2019
Labeler - The Saem International Co., Ltd. (689402402)
Registrant - The Saem International Co., Ltd. (689402402)
Establishment
NameAddressID/FEIBusiness Operations
Hankook Cosmetics Manufacturing Co.,Ltd_Eumseong Factory688235645manufacture(70341-020)

Revised: 12/2019
Document Id: 17b89761-8feb-4a6a-ace8-44226f6d6672
Set id: d039ec7c-ab70-4315-a804-e1e077a63305
Version: 2
Effective Time: 20191228
 
The Saem International Co., Ltd.