DR. GLODERM TABRX WHITENING- niacinamide cream

DR. GLODERM TABRX WHITENING by

Drug Labeling and Warnings

DR. GLODERM TABRX WHITENING by is a Otc medication manufactured, distributed, or labeled by DR.GLODERM, SAMSUNG MEDICOS. CO., LTD. Hyangnam Factory. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Niacinamide

INACTIVE INGREDIENT

Water, Butylene Glycol, Glycerin etc.

PURPOSE

Skin Protectant - Whitening

KEEP OUT OF REACH OF CHILDREN

keep out of reach of the children

INDICATIONS & USAGE

It's melting on the pam taken two capsules with spatula at the last stage of skin care, and apply on the entire face.

Gently pat to help absorption into the skin.

* Do not eat capsules.

WARNINGS

1. If the following symptoms occur after product use, stop using the product immediately and consult a dermatologist (continuous use can exacerbate the symptoms).

1) Occurrence of red spots, swelling, itchiness, and other skin irritation

2) If the symptoms above occur after the application area is exposed to direct sunlight

2. Do not use on open wounds, eczema, and other skin irritations

3. Precaution for Storage and Handling

1) Close the lid after use

2) Keep out of reach of infants and children

3) Do not to store in a place with high/low temperature and exposed to direct sunlight

4. Use as avoiding eye areas.

DOSAGE & ADMINISTRATION

for external use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DR. GLODERM TABRX WHITENING 
niacinamide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71342-0012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	2.14 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71342-0012-1	45 g in 1 JAR; Type 0: Not a Combination Product	03/28/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/01/2017

Labeler - DR.GLODERM (694773267)

Registrant - DR.GLODERM (694773267)

Establishment
Name	Address	ID/FEI	Business Operations
SAMSUNG MEDICOS. CO., LTD. Hyangnam Factory		689851701	manufacture(71342-0012)

Establishment
Name	Address	ID/FEI	Business Operations
DR.GLODERM		694773267	label(71342-0012)