PANDAS DREAM SO COOL EYE SERUM- dimethicone stick 
TONYMOLY 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 1.0%

INACTIVE INGREDIENT

Inactive Ingredient: Water, Butylene Glycol, Sodium Stearate, Alcohol, Xylitol, PEG-12 Dimethicone, Glycerin, PEG-8, Bis-PEG-18 Methyl Ether Dimethyl Silane, Niacinamide, Sodium Citrate, Potassium Alginate, Methyl Methacrylate Crosspolymer, Xanthan Gum, Phenoxyethanol, Citric Acid, Actinidia Arguta Fruit Extract, Sea Water, Bambusa Vulgaris Shoot Extract, Bambusa Vulgaris Sap Extract, Glacier Water, Fragrance, Adenosine, Steareth-20, Caprylyl Glycol, 1,2-Hexanediol, CI 42090, Caprylhydroxamic Acid, N-Hydroxysuccinimide, Chlorhexidine Digluconate, Potassium Sorbate, Chrysin, Palmitoyl Oligopeptide, Palmitoyl Tetrapeptide-7, Tropolone

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warnings: For external use only When using this product do not get into eyes Stop use and ask a doctor if rash occurs Do not use on - deep puncture wounds - animal bites - serious burns Keep out of reach of children

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Use

Use: Helps prevent and relieve chapped or cracked skin

Directions

Directions: - Clean the skin thoroughly before using - Apply in daily skin care routine

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

PANDAS DREAM SO COOL EYE SERUM 
dimethicone stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59078-314
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone0.09 g  in 9 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59078-314-021 in 1 CARTON05/01/2016
1NDC:59078-314-019 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34705/01/2016
Labeler - TONYMOLY CO.,LTD (688216798)
Registrant - TONYMOLY CO.,LTD (688216798)
Establishment
NameAddressID/FEIBusiness Operations
TONYMOLY CO.,LTD688216798manufacture(59078-314)

Revised: 6/2016
Document Id: 70a71753-0ede-4086-9d36-ebe2a2fda76a
Set id: 619376f9-7f33-4c8b-92ea-eae26d6b4069
Version: 1
Effective Time: 20160616
 
TONYMOLY CO.,LTD