THERA Dimethicone Body Shield

Dosage form: cream
Ingredients: DIMETHICONE 50uL in 1mL
Labeler: McKesson Medical-Surgical Inc.
NDC Code: 68599-0203

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 ingredientDimethicone 5.0%

PurposeSkin Protectant

Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.

Uses
  • 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 THERATM Moisturizing Body Cleanser or THERATM Foaming Body Cleanser
  • Apply cream liberally until entire area is covered
  • Apply as needed

Other information
  • Protect from freezing. Avoid excessive heat.

Inactive ingredients

Aleurites Moluccana Seed Oil, Aloe Barbadensis (Aloe Vera) Lead Juice, SAFFLEXTM (Consisting of: Calcium Pantothenate (Vitamin B5), Maltodextrin, Niacinamide (Vitamin B3), Pyridoxine HCl (Vitamin B6), 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

THERA DIMETHICONE BODY SHIELD 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68599-0203
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (DIMETHICONE) DIMETHICONE50 uL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
KUKUI NUT OIL 
ALOE VERA LEAF 
CALCIUM PANTOTHENATE  
MALTODEXTRIN 
NIACINAMIDE 
PYRIDOXINE HYDROCHLORIDE 
SILICON DIOXIDE 
SODIUM ASCORBYL PHOSPHATE 
.ALPHA.-TOCOPHEROL ACETATE, DL- 
LEVOMENOL 
BUTYLENE GLYCOL 
CAPRYLYL GLYCOL 
SAFFLOWER OIL 
CETYL ALCOHOL 
CHLORPHENESIN 
EDETATE DISODIUM 
GLYCERIN 
GLYCERYL MONOSTEARATE 
PEG-100 STEARATE 
PHENOXYETHANOL 
WATER 
HYALURONATE SODIUM 
STEARIC ACID 
TROLAMINE 
GINGER 
Packaging
#Item CodePackage Description
1NDC:68599-0203-4118 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34709/01/2011
Labeler - McKesson Medical-Surgical Inc. (023904428)
Registrant - PureTek Corporation (785961046)
Establishment
NameAddressID/FEIOperations
PureTek Corporation785961046manufacture, label, pack, outsourcing human drug compounding, relabel, repack

Revised: 09/2011
 
McKesson Medical-Surgical Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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