ULTIMATE SKIN PROTECTANT DERMA SHIELD- dimethicone aerosol 
Fleet Laboratories LTD

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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Ultimate Skin Protectant Derma Shield

Active ingredient Purpose

Dimethicone 2.7% Skin Protectant

Uses

Keep out of reach of children

Stop use and ask a doctor if:

Warnings

For external use only

Flammable:

Directions

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, Perfluorianted Polyether, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Lanolin, Tetrasodium EDTA, Propylene Glycol Diazolidinyl Urea, Methylparaben, Propylparaben, Sodium Benzoate, Potassium Sorbate,Citric Acid.

Benchmark's

DermaShield

The Ultimate Skin Protectant

Net Weight 17 oz(1lb 1 oz) (482g)

17 oz -6 US

ULTIMATE SKIN PROTECTANT DERMA SHIELD 
dimethicone aerosol
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70233-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE2.7 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ISOBUTANE (UNII: BXR49TP611)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
EDETATE SODIUM (UNII: MP1J8420LU)  
LANOLIN (UNII: 7EV65EAW6H)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
PALM KERNEL ACID (UNII: 79P21R4317)  
COPOVIDONE K25-31 (UNII: D9C330MD8B)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
PALMITIC ACID (UNII: 2V16EO95H1)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
PERFLUOROPOLYMETHYLISOPROPYL ETHER (UNII: X6324K3MBW)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
PROPANE (UNII: T75W9911L6)  
BUTANE (UNII: 6LV4FOR43R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70233-010-01482 g in 1 CAN; Type 0: Not a Combination Product10/14/2019
2NDC:70233-010-02170 g in 1 CAN; Type 0: Not a Combination Product10/14/2019
3NDC:70233-010-0357 g in 1 CAN; Type 0: Not a Combination Product10/14/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34710/14/2019
Labeler - Fleet Laboratories LTD (217269489)
Establishment
NameAddressID/FEIBusiness Operations
FLEET LABORATORIES LTD217269489manufacture(70233-010)

Revised: 10/2019
Document Id: 941cf550-4e0b-0b58-e053-2995a90a64a9
Set id: 941cf550-4e0a-0b58-e053-2995a90a64a9
Version: 1
Effective Time: 20191004
 
Fleet Laboratories LTD