AC7 by MICELL KOREA CO.,LTD AC7- acne serum gel

AC7 by

Drug Labeling and Warnings

AC7 by is a Otc medication manufactured, distributed, or labeled by MICELL KOREA CO.,LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Salicylic Acid (0.01%) - Acne treatment

INACTIVE INGREDIENT

Water, Butylene Glycol, Silica, Glycerin, Niacinamide, Sodium Hyaluronate, Polyglutamic acid, Methionine, Serine, Histidine, 1,2-Hexandiol, Hydroxyethylethylcelluose, Bacopa Monniera Extract, Hydroxyethylcellulose, Propylene Glycol, Camellia Sinensis Leaf Extract, Citrus Aurantium Bergamia (Bergamot) Leaf Extract, Lavendula Angustifolia (Lavender) Flower Extract, Rosa Centifolia Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Ethylhexylglycerin, Belamcanda Chinensis Root Extract, Calcium Pantothenate, Sodium Ascorbyl Phosphate, Tocopheryl Acetate, Pyridoxine HCl, Maltodextrin / Sodium Starch Octenylsuccinate, Centella Asiatica Extract, Polygonum Cuspidatum Root Extract, Scutellaria Baicalensis Root Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Chamomilla Recutita (matricaria) Flower Extract, Portulaca Oleracea Extract, Phellodendron Amurense Bark Extract, Coptis Chinensis Root Extract, Octanediol, Citrus grandis (grapefruit) seed extract, Artemisia princeps extract, Carbomer, Triethanolamine, Dimethyl Sulfone, Aloe Barbadensis Leaf Extract, Phenoxyethanol, Luffa Cylindrica Fruit Extract, Alcohol, Dryopteris Filix-Mas Root Extract, Allantoin, Dipotassium Glycyrrhizate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Disodium EDTA

PURPOSE

For the treatment of acne

WARNINGS

For external use only.
Do not use
 on puncture wounds  on animal bites  on serious burns  on area with scratches, eczema, or dermatitis
When using this product
 avoid contact with eyes, lips and mouth
 avoid unnecessary sun exposure
Stop use and ask a doctor if
 skin irritation or sensitivity develops or increases

KEEP OUT OF REACH OF CHILDREN

 if swallowed, get medical help or contact a Poison Control Center right away

INDICATIONS & USAGE

 Clean your hand before use
 After cleansing in the evening, put the finger wrap that is attached in the package, and apply an appropriate amount to the fingers of the finger wrap, and then, and then apply it horizontally and vertically crosswise to the trouble area and then absorb it
 Be careful not to get in your eyes.
 You can follow inserted instruction for use for the better effect

DOSAGE & ADMINISTRATION

 Clean your hand before use
 After cleansing in the evening, put the finger wrap that is attached in the package, and apply an appropriate amount to the fingers of the finger wrap, and then, and then apply it horizontally and vertically crosswise to the trouble area and then absorb it
 Be careful not to get in your eyes.
 You can follow inserted instruction for use for the better effect

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

AC7 
acne serum gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71327-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Salicylic Acid (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	Salicylic Acid	0.000001 g  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Butylene Glycol (UNII: 3XUS85K0RA)
Methionine (UNII: AE28F7PNPL)
Serine (UNII: 452VLY9402)
Histidine (UNII: 4QD397987E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71327-001-01	10 mL in 1 PACKAGE; Type 0: Not a Combination Product	03/20/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/20/2017

Labeler - MICELL KOREA CO.,LTD (689851542)

Registrant - MICELL KOREA CO.,LTD (689851542)

Establishment
Name	Address	ID/FEI	Business Operations
MICELL KOREA CO.,LTD		689851542	manufacture(71327-001)