Drug Labeling and Warnings

Drug Details [pdf]

ALWAYS PURE SPOT FOR NIGHT- salicylic acid cream 
DMS INTERNATIONAL 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 0.4%

INACTIVE INGREDIENT

Inactive Ingredients: Isopropyl Alcohol, Water, Calamine, Glycerin, Zinc Oxide, Titanium Dioxide, Camphor, Centella Asiatica Extract, Sulfur, Chamomilla Recutita (Matricaria) Flower Extract, Calendula Officinalis Flower Extract, Allantoin, PEG-60 Almond Glycerides, Caprylyl Glycol, Carbomer, Oleanolic Acid, Butylene Glycol, Nordihydroguaiaretic Acid, Phenoxyethanol

PURPOSE

Purpose: Purpose: Antiacne

WARNINGS

Warnings: 1. If the following side effects occur, immediately discontinue use. Before resuming use, consult a dermatologist as continual use may worsen symptoms. A) If red spots, swelling, itching, irritation, or other discomforts occur after using the product. B) If the above symptoms occur on the applied area after exposure to direct sunlight. 2. Do not use on open wounds or on areas of skin exhibiting signs of eczema or dermatitis. 3. Storage and handling precautions A) Keep product out of reach of infants and children. B) Ensure that lid is closed after use. C) Do not store in places subject to high or cold temperatures or under exposure to direct sunlight. D) Use care to avoid eye contact when using this product.

KEEP OUT OF REACH OF CHILDREN

Keep product out of reach of infants and children.

INDICATIONS & USAGE

Indications & usage: 1. Do not shake and wait for pink powder go down. 2. Get proper amount of pink powder using cotton swab. 3. Apply it spot trouble areas.

DOSAGE & ADMINISTRATION

Dosage & Administration: Use immediately after opening.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

ALWAYS PURE SPOT FOR NIGHT 
salicylic acid cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70265-130
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Salicylic Acid (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) Salicylic Acid0.08 g  in 20 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70265-130-0120 mL in 1 CARTON; Type 0: Not a Combination Product02/01/201601/02/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D02/01/201601/02/2019
Labeler - DMS INTERNATIONAL CO., LTD. (688309194)
Registrant - DMS INTERNATIONAL CO., LTD. (688309194)
Establishment
NameAddressID/FEIBusiness Operations
DMS INTERNATIONAL CO., LTD.688309194manufacture(70265-130)

Revised: 8/2019
 
DMS INTERNATIONAL CO., LTD.