DR.ZIUM ALL CLEAR SPOT- salicylic acid cream

Dr.zium All Clear Spot by

Drug Labeling and Warnings

Dr.zium All Clear Spot by is a Otc medication manufactured, distributed, or labeled by GM Holdings Co., Ltd, Cosmax, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Salicylic Acid

INACTIVE INGREDIENT

Niacinamide, Terminalia Ferdinandiana Fruit Extract, Aazelaoyl Octapeptide-9, Water, etc

PURPOSE

Acne Treatment

KEEP OUT OF REACH OF CHILDREN

keep out of reach of the children

INDICATIONS & USAGE

Apply an adequate amount to the trouble area and absorb with gentle dabbing

WARNINGS

Warnings

Do not use if you have very sensitive skin or are sensitive to Salicylic Acid

Ask a doctor or pharmacist before use if you are using other topical acne medications at the same time or immediately following use of this product. This may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

For external use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DR.ZIUM ALL CLEAR SPOT 
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69278-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.00001 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
KAKADU PLUM (UNII: 0ZQ1D2FDLI)
WATER (UNII: 059QF0KO0R)
NIACINAMIDE (UNII: 25X51I8RD4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69278-001-01	15 mL in 1 TUBE; Type 0: Not a Combination Product	01/17/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	01/17/2018

Labeler - GM Holdings Co., Ltd (688439958)

Registrant - GM Holdings Co., Ltd (688439958)

Establishment
Name	Address	ID/FEI	Business Operations
GM Holdings Co., Ltd		688439958	label(69278-001)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc.		689049693	manufacture(69278-001)