Drug Labeling and Warnings

Drug Details [pdf]

ALWAYS PURE FIRST AID- glycerin cream 
DMS INTERNATIONAL 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.

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ACTIVE INGREDIENT

Active Ingredient: Glycerin 3.0%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Alcohol, Cetyl Caprylate, Caprylic/Capric Triglyceride, Urea, 1,2-Hexanediol, C11-15 Pareth-12, PEG-40 Hydrogenated Castor Oil, Carbomer, Triethanolamine, Centella Asiatica Extract, Houttuynia Cordata Extract, Citrus Paradisi (Grapefruit) Fruit Extract, Eucalyptus Globulus Leaf Extract, Eugenia Caryophyllus (Clove) Flower Extract, Sophora Angustifolia Root Extract, Bambusa Vulgaris Extract, Punica Granatum Fruit Extract, Bee Venom, Arginine, Hydrogenated Lecithin, Glycyrrhiza Glabra (Licorice) Root Extract, Lavandula Angustifolia (Lavender) Extract, Artemisia Vulgaris Extract, Cucumis Sativus (Cucumber) Fruit Extract, Caprylhydroxamic Acid, Caprylyl Glycol, Butylene Glycol

PURPOSE

Purpose: Skin protectant

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: After cleansing, take a proper amount of it and apply evenly on the whole face. Absorb it by tapping softly with end of finger up.

DOSAGE & ADMINISTRATION

Dosage & Administration: Use immediately after opening.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

ALWAYS PURE FIRST AID 
glycerin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70265-120
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Glycerin (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) Glycerin1.8 g  in 60 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Alcohol (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70265-120-0160 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
unapproved drug other02/01/201601/02/2019
Labeler - DMS INTERNATIONAL CO., LTD. (688309194)
Registrant - DMS INTERNATIONAL CO., LTD. (688309194)
Establishment
NameAddressID/FEIBusiness Operations
DMS INTERNATIONAL CO., LTD.688309194manufacture(70265-120)

Revised: 8/2019