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Benchmarks Derma Shield by Fillcare Limited

Dosage form: aerosol
Ingredients: DIMETHICONE 2.7g in 100g
Labeler: Fillcare Limited
NDC Code: 69881-003

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.

Active Ingredient

Dimethicone, 2.7%

Purpose

Skin protectant

Keep Out of Reach of Children

Do not use on:

  • deep or puncture wounds
  • animal bites
  • serious bites

Uses

  • helps prevent and temporarily protects and helps relieve chafed, chapped or cracked skin
  • helps prevent and protect from the drying effects of wind and cold weather

Warnings

For external use only

Flammable:

  • Do not use near flame or spark or while smoking
  • Contents under pressure
  • Do not puncture or incinerate
  • Do not store at temperature above 120 oF

When using this product:

  • do not get into eyes

Stop use and ask doctor if:

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Dosage and Administration

  • Apply as needed
  • Children under 6 months: ask a doctor
  • Wash and dry skin area
  • Shake can vigorously
  • invert can and apply "golf ball" size in palm
  • Rub thoroughly onto the skin
  • Allow to dry

Inactive ingredients

  • Water
  • Propane
  • Butane
  • Palmitic Acid
  • Palm Kernal Acid
  • Isopropyl Myristate
  • Glycerin
  • VP/VA Copolymer
  • Isobutane
  • Triethanolamine
  • Cetyl Alcohol
  • Cetearyl Alcohol
  • Ceteareth-20
  • Hydroxyethylcellulose
  • Perfluorinated Polyether
  • Aloe Barbadensis Leaf Juice
  • Tocopheryl Acetate
  • Landin
  • Tetrasodium EDTA
  • Propylene
  • Glycol Diazolidinyl Urea
  • Methylparaben
  • Propylparaben
  • Sodium Benzoate
  • Potassium Sorbate
  • Citric Acid

BENCHMARKS DERMA SHIELD 
dimethicone aerosol
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69881-003
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (DIMETHICONE) DIMETHICONE2.7 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
WATER 
BUTANE 
CETOSTEARYL ALCOHOL 
CITRIC ACID MONOHYDRATE 
DIAZOLIDINYL UREA 
GLYCERIN 
ISOBUTANE 
ISOPROPYL MYRISTATE 
LANOLIN 
METHYLPARABEN 
PALM KERNEL ACID 
PALMITIC ACID 
PERFLUOROPOLYMETHYLISOPROPYL ETHER 
POTASSIUM SORBATE 
PROPANE 
PROPYLENE GLYCOL 
PROPYLPARABEN 
SODIUM BENZOATE 
EDETATE SODIUM 
.ALPHA.-TOCOPHEROL ACETATE 
TROLAMINE 
COPOVIDONE K25-31 
POLYOXYL 20 CETOSTEARYL ETHER 
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) 
Packaging
#Item CodePackage Description
1NDC:69881-003-0157 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/23/201604/01/2023
Labeler - Fillcare Limited (227632171)
Establishment
NameAddressID/FEIOperations
Fillcare Limited227632171manufacture(69881-003)

 
Fillcare Limited

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Medically reviewed on Jun 25, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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