BAROX WHITE GOLF by Barox Co., Ltd. / Gdkcosmetics Co., Ltd.

BAROX WHITE GOLF by

Drug Labeling and Warnings

BAROX WHITE GOLF by is a Otc medication manufactured, distributed, or labeled by Barox Co., Ltd., Gdkcosmetics Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BAROX WHITE GOLF- niacinamide cream 
Barox 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 Ingredient: Niacinamide 7.0%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Butylene Glycol, Mineral Oil, Petrolatum, Cetyl Ethylhexanoate, Glycerin, Glyceryl Stearate, Cetearyl Alcohol, Arbutin, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Beeswax, Macadamia Ternifolia Seed Oil, Stearic Acid, Dimethicone, Sorbitan Sesquioleate, PEG-100 Stearate, PEG-40 Stearate, PEG-20 Stearate, Triethanolamine, Phenoxyethanol, Carbomer, Methylparaben, Fragrance, Silk Amino Acids, Tocopheryl Acetate, Propylparaben, Disodium EDTA, Dimethyl Sulfone, Sodium Hyaluronate, Ethylhexylglycerin, Avena Strigosa Seed Extract, Morinda Citrifolia Extract, Lavandula Angustifolia (Lavender) Extract, Melissa Officinalis Extract, Oryza Sativa (Rice) Extract, Aloe Barbadensis Leaf Juice, Usnea Barbata (Lichen) Extract, Zanthoxylum Piperitum Fruit Extract

PURPOSE

Purpose: Skin Protectant (Brightening)

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

Indications & Usage: Pump 1-2 times and spread following the skin texture, tap lightly for better absorption

DOSAGE & ADMINISTRATION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BAROX WHITE GOLF 
niacinamide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55692-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Niacinamide (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	Niacinamide	3.5 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Butylene Glycol (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55692-010-01	50 mL in 1 CARTON; Type 0: Not a Combination Product	11/01/2015	03/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/01/2015	03/01/2019

Labeler - Barox Co., Ltd. (688380051)

Registrant - Barox Co., Ltd. (688380051)

Establishment
Name	Address	ID/FEI	Business Operations
Gdk cosmetics Co., Ltd.		557821946	manufacture(55692-010)

Revised: 11/2019

Document Id: 314eaa2f-4f12-4ea6-af65-bc34babaabe4

34390-5

Set id: a82a5204-c4bf-42bf-9121-68b363fee41b

Version: 3

Effective Time: 20191107

 

Barox Co., Ltd.