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Name:Acpurisintensive Spot Treatment
Manufacturer:Mediway Korea Co., Ltd.
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

ACPURIS INTENSIVE SPOT TREATMENT - salicylic acid cream 
MEDIWAY KOREA CO., LTD.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active Ingredient: Salicylic Acid

Inactive Ingredients:

Water, Glycerin, Cyclopentasiloxane, Dimethicone, Butylene Glycol, Centella Asiatica Extract, PEG-10 Dimethicone Crosspolymer, Beta-Glucan,
Arbutin, Piper Methysticum Leaf/Root/Stem Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Methylparaben, Phellinus Linteus Extract,
Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Squalane, Imidazolidinyl Urea, Polysorbate 60, Dipotassium Glycyrrhizate,
Biosaccharide Gum-1, Sodium Metabisulfite, Disodium EDTA, Benzophenone-9, Sodium Hyaluronate, Betaine, Aloe Barbadensis Leaf Juice,
Melaleuca Alternifolia (Tea Tree) Leaf Oil

Purpose: For oily and trouble skin daily control.

Warnings:

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.
   - In case of having problems such as red rash, swollenness, itching, stimulationduring usage.
   - In case of having the same symptoms above on the part you put this product on by direct sunlight.
You are banned to use it on the part where you have a scar, eczema, or dermatitis.

Keep out of reach of children:

Keep out of reach of children.

Uses:

Active ingredients of ACPURIS Intensive spot treatment help to clear existing skin troubles and prevent future breakouts.

Dosage and administration:

Apply to the targeted area (The use of applicator of cosmetic pads is recommended)

Image of carton


ACPURIS  INTENSIVE SPOT TREATMENT
salicylic acid cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52797-020
Route of Administration CUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 0.3 mL  in 15 mL
Inactive Ingredients
Ingredient Name Strength
Water  
Glycerin  
Dimethicone  
Butylene Glycol  
Arbutin  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52797-020-01 15 mL in 1 CARTON None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333D 09/01/2010

Labeler - MEDIWAY KOREA CO., LTD. (557784983)
Registrant - MEDIWAY KOREA CO., LTD. (557784983)
Establishment
Name Address ID/FEI Operations
MEDIWAY KOREA CO., LTD. 557784983 manufacture

Revised: 02/2011 MEDIWAY KOREA CO., LTD.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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