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:

Stop use and ask dermatologist or doctor if

•signs of redness, skin swelling, itchy spots, irritation or rash and other appear

•the above signs appear in the applied area by direct rays of the sun

Do not use over

•wounds rashes inflammations other troubled areas.

When using

•Avoid the eye area

•must close the cap after using

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children:

If swallowed, get medical help or contact a Poison Control Center right away.

Uses

Uses: For the treatment of acne

Directions

Directions:

•Dispense appropriate amount on your hand.

•Make foam by adding small amount of water.

•Gently massage the whole face then rinse thoroughly.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

28 REMEDY ACNE PORE DEEP CLEANSER 
salicylic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69716-080
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Salicylic Acid (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) Salicylic Acid0.6 g  in 120 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69716-080-01120 mL in 1 CARTON; 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(69716-080)

Revised: 12/2018
 
NoTS Co.,Ltd