Drug Labeling and Warnings

Drug Details [pdf]

ALWAYS SMOOTH REVOLUTION AMPLE- dimethicone 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: Dimethicone 2.1%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Glycerin, Butylene Glycol, PEG-32, PEG/PPG-17/6 Copolymer, Hyaluronic Acid, 1,2-Hexanediol, Polysorbate 60, Sorbitol, Acrylates/C10-30 AlkylAcrylate Crosspolymer, Arginine, Sorbitan Sesquioleate, Ethylhexylglycerin, Betaine, Allantoin, Panthenol, Cyclopentasiloxane, Trideceth-6, PEG/PPG-18/18 Dimethicone, Sodium Polyacrylate, Adenosine, Disodium EDTA, Daucus Carota Sativa (Carrot)Root Extract, Soluble Collagen, Glycine Soja (Soybean) GermExtract, Tocopheryl Acetate, Ceramide 3

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: At daily skin care, after using tonic and take a proper amount 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 SMOOTH REVOLUTION AMPLE 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70265-160
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone2.1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70265-160-01100 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 finalpart34702/01/201601/02/2019
Labeler - DMS INTERNATIONAL CO., LTD. (688309194)
Registrant - DMS INTERNATIONAL CO., LTD. (688309194)
Establishment
NameAddressID/FEIBusiness Operations
Nowcos.Co.,Ltd689914984manufacture(70265-160)

Revised: 8/2019