DR.ALTHEA HYDRATION BOOSTING 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

SQUALANE,HYDROLYZED HYALURONIC ACID,ALGAE EXTRACT,WATER,BUTYLENE GLYCOL,ETC

Helps Hydrate skin

keep out of reach of the children

After using a skin toner, apply this product to skin and spread it over skin evenly once or twice every morning and night.

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

label

DR.ALTHEA HYDRATION BOOSTING SERUM 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70905-0003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70905-0003-150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/11/2016
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(70905-0003)

Revised: 8/2016
Document Id: 39d7a5d2-67a1-4c08-e054-00144ff8d46c
Set id: 90aa6528-f49e-4cf0-bca4-fe6ae9ddb575
Version: 1
Effective Time: 20160812
 
Dr. Althea