AC7- acne serum gel 
MICELL KOREA LAB 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.

----------

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

image description

AC7 
acne serum gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71327-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Salicylic Acid (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) Salicylic Acid0.000001 g  in 10 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Methionine (UNII: AE28F7PNPL)  
Serine (UNII: 452VLY9402)  
Histidine (UNII: 4QD397987E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71327-001-0110 mL in 1 PACKAGE; Type 0: Not a Combination Product03/20/201703/20/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/20/201703/20/2017
Labeler - MICELL KOREA LAB CO., LTD (689851542)
Registrant - MICELL KOREA LAB CO., LTD (689851542)

Revised: 8/2021
 
MICELL KOREA LAB CO., LTD