Label: BENCHMARKS DERMA SHIELD- dimethicone aerosol
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Contains inactivated NDC Code(s)
NDC Code(s): 80905-001-01, 80905-001-02, 80905-001-03 - Packager: STAR COLOUR LABORATORIES
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 Label Information
Updated October 9, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient(s)
- Uses
- Purpose
- Warnings
- Do not use on:
- Directions
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Inactive ingredients
Water, Propane, Butane, Palmitic acid, Palm Kernal acid, Isopropyl Myrisate, 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 Diazolindinyl Urea, Methylparaben, Propylparaben, Sodium Benzoate, Potassium Sorbate, Citric Acid
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BENCHMARKS DERMA SHIELD
dimethicone aerosolProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80905-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 2.7 g in 100 g Inactive Ingredients Ingredient Name Strength LANOLIN (UNII: 7EV65EAW6H) PROPYLPARABEN (UNII: Z8IX2SC1OH) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) GLYCERIN (UNII: PDC6A3C0OX) HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45) METHYLPARABEN (UNII: A2I8C7HI9T) PALM KERNEL ACID (UNII: 79P21R4317) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM BENZOATE (UNII: OJ245FE5EU) COPOVIDONE K25-31 (UNII: D9C330MD8B) EDETATE SODIUM (UNII: MP1J8420LU) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TROLAMINE (UNII: 9O3K93S3TK) ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) CETYL ALCOHOL (UNII: 936JST6JCN) ISOBUTANE (UNII: BXR49TP611) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) PALMITIC ACID (UNII: 2V16EO95H1) PERFLUOROPOLYMETHYLISOPROPYL ETHER (UNII: X6324K3MBW) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) PROPANE (UNII: T75W9911L6) BUTANE (UNII: 6LV4FOR43R) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80905-001-03 482 g in 1 CAN; Type 0: Not a Combination Product 10/09/2020 2 NDC:80905-001-02 170 g in 1 CAN; Type 0: Not a Combination Product 10/09/2020 3 NDC:80905-001-01 57 g in 1 CAN; Type 0: Not a Combination Product 10/09/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 10/09/2020 Labeler - STAR COLOUR LABORATORIES (215970015) Establishment Name Address ID/FEI Business Operations STAR COLOUR LABORATORIES 215970015 manufacture(80905-001)
