Country: United States
Language: English
Source: NLM (National Library of Medicine)
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)
McKesson Medical-Surgical Inc.
DIMETHICONE
DIMETHICONE 50 uL in 1 mL
TOPICAL
OTC DRUG
- For the treatment and/or prevention of diaper rash - Temporarily protects and helps relieve chapped or cracked skin
OTC monograph final
THERA DIMETHICONE BODY SHIELD - DIMETHICONE CREAM MCKESSON MEDICAL-SURGICAL INC. _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 ACTIVE INGREDIENT Dimethicone 5.0% PURPOS E Skin Protectant KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away. US ES For the treatment and/or prevention of diaper rash Temporarily protects and helps relieve chapped or cracked skin WARNINGS FOR EXTERNAL USE ONLY DO NOT USE ON deep or puncture wounds animal bites serious burns WHEN USING THIS PRODUCT do not get into eyes STOP USE AND ASK A DOCTOR IF condition worsens symptoms last more than 7 days or clear up and occur again within a few days DIRECTIONS Cleanse skin with THERA Moisturizing Body Cleanser or THERA Foaming Body Cleanser Apply cream liberally until entire area is covered Apply as needed OTHER INFORMATION Protect from freezing. Avoid excessive heat. TM TM INACTIVE INGREDIENTS Aleurites Moluccana Seed Oil, Aloe Barbadensis (Aloe Vera) Lead Juice, SAFFLEX (Consisting of: Calcium Pantothenate (Vitamin B ), Maltodextrin, Niacinamide (Vitamin B ), Pyridoxine HCl (Vitamin B ), Silica, Sodium Ascorbyl Phosphate (Vitamin C), Sodium Starch Octenylsuccinate, Tocopheryl Acetate (Vitamin E)), Bisabolol, Butylene Glycol, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Oleosomes, Carthamus Tintorius (Safflower) Seed Oil, Cetyl Alcohol, Chlorphenesin, Dimethicone Crosspolymer, Disodium EDTA, Glycerin, Glyceryl Stearate, Lavender Ylang Fragrance, PEG-100 Stearate, Pentaery Tetra-di-t-Butyl Hydroxyhydrocinnamate, Phenoxyethanol, Purified Water, Sodium Hyaluronate, Stearic Acid, Triethanolamine, Zingiber (Ginger) Root Extract. LABEL TM 5 3 6 THERA DIMETHICONE BODY SHIELD dimethicone cream PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:6 8 59 9 -0 20 3 ROUTE OF ADMINISTRATION TOPICA Read the complete document