DR.ALTHEA TO BE EYECONIC EYE SERUM- dimethicone cream 
Dr. Althea

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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Drug Facts

DIMETHICONE

WATER, CYCLOPENTASILOXANE, BUTYLENE GLYCOL, GLYCERIN, TOCOPHEROL, ETC.

Skin Protectant

keep out of reach of the children

Take appropriate amount of eye serum evenly spread on the skin

1. If the following symptoms occur after product use, stop using the product immediately and consult a dermatologist (continuous use can exacerbate the symptoms).
1) Occurrence of red spots, swelling, itchiness, and other skin irritation
2) If the symptoms above occur after the application area is exposed to direct sunlight
2. Do not use on open wounds, eczema, and other skin irritations
3. Precaution for Storage and Handling
1) Close the lid after use
2) Keep out of reach of infants and children
3) Do not to store in a place with high/low temperature and exposed to direct sunlight

for external use only

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DR.ALTHEA TO BE EYECONIC EYE SERUM 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70905-0010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE6.0192 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70905-0010-11 in 1 PACKAGE08/11/2016
120 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34708/11/2016
Labeler - Dr. Althea (689694436)
Registrant - Dr. Althea (689694436)
Establishment
NameAddressID/FEIBusiness Operations
Dr. Althea689694436manufacture(70905-0010)

Revised: 10/2016
Document Id: 3e911ad6-52b1-5cd3-e054-00144ff88e88
Set id: 3e911ad6-52b0-5cd3-e054-00144ff88e88
Version: 1
Effective Time: 20161011
 
Dr. Althea