Drug Labeling and Warnings

Drug Details [pdf]

NOTS 28 REMEDY ACNE PORE DEEP CLEANSER- salicylic acid gel 
NoTS 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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ACTIVE INGREDIENT

Active Ingredient: Salicylic Acid 0.50%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Glycerin, Palmitic Acid, Stearic Acid, Lauric Acid, Myristic Acid, Potassium Hydroxide, Glyceryl Stearate SE, Cocamide DEA, Propylene Glycol, Beeswax, Cocamidopropyl Betaine, Glycol Distearate, PEG-60 Hydrogenated Castor Oil, Sodium Chloride, Sophora Angustifolia Root Extract, Tocopheryl Acetate, Disodium EDTA, Methylparaben, Butylparaben, BHT, Glycyrrhiza Glabra (Licorice) Root Extract, Daucus Carota Sativa (Carrot) Root Extract, Allium Sativum (Garlic) Bulb Extract, Centella Asiatica Extract, Hedera Helix (Ivy) Extract, Aloe Barbadensis Leaf Juice, Betula Alba Juice, Carum Petroselinum (Parsley) Extract, Butylene Glycol, Camellia Sinensis Leaf Extract

PURPOSE

Purpose: Anti acne cleanser

WARNINGS

Warnings: 1. Discontinue use if the following abnormal situations occur. If you continue to use, it may worsen symptoms, consult a dermatologist etc. A) If sings of redness, skin swelling, itchy spots, irritation or rash etc appear B) If the above signs appear in the applied area by direct rays of the sun 2. Do not use over wounds, rashes, inflammations or other troubled areas. 3. Notice when maintaining and handling A) You must close the cap after using B) Keep out of reach of children C) Do not keep in the place of high or low temperature and in direct sunlight.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

INDICATIONS & USAGE

Indications & usage: Taking the appropriate amounts and fully making foams with a small amount of water, gently massage the whole face and then rinse with tepid water.

DOSAGE & ADMINISTRATION

Dosage & administration: Apply adequate amount of this product.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of tube

NOTS 28 REMEDY ACNE PORE DEEP CLEANSER 
salicylic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 69716-180
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Salicylic Acid (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) Salicylic Acid0.1 g  in 20 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 69716-180-0120 mL in 1 TUBE; Type 0: Not a Combination Product01/02/201612/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D01/02/201612/01/2018
Labeler - NoTS Co.,Ltd (689004599)
Registrant - NoTS Co.,Ltd (689004599)
Establishment
NameAddressID/FEIBusiness Operations
Nowcos.Co.,Ltd689914984manufacture(69716-180)

Revised: 5/2019
 
NoTS Co.,Ltd