Country: United States
Language: English
Source: NLM (National Library of Medicine)
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)
Dr. Althea
DIMETHICONE
DIMETHICONE 2 g in 100 mL
TOPICAL
OTC DRUG
Helps Hydrate skin After using a skin toner, apply this product to skin and spread it over skin evenly once or twice every morning and night.
OTC monograph final
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._ ---------- 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 Dr. Althea DR.ALTHEA HYDRATION BOOSTING SERUM dimethicone cream PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:70 9 0 5-0 0 0 3 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH DIMETHICO NE (UNII: 9 2RU3N3Y1O) (DIMETHICONE - UNII:9 2RU3N3Y1O) DIMETHICONE 2 g in 10 0 mL INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH WATER (UNII: 0 59 QF0 KO0 R) BUTYLENE GLYCO L (UNII: 3XUS8 5K0 RA) PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:70 9 0 5-0 0 0 3- 1 50 mL in 1 BOTTLE, PUMP; Type 0 : No t a Co mbinatio n Pro duc t 0 8 /11/20 16 MARKETING INFORMATION MARKE TING CATE GORY APPLICATION NUMBE R OR MONOGRAPH CITATION MARKE TING START DATE MARKE TING END DATE OTC mo no graph final pa rt347 0 8 /11/20 16 LABELER - Dr. Althea (689694436) REGISTRANT - Read the complete document