BENCHMARKS DERMA SHIELD- dimethicone aerosol

Benchmarks Derma Shield by

Drug Labeling and Warnings

Benchmarks Derma Shield by is a Otc medication manufactured, distributed, or labeled by STAR COLOUR LABORATORIES. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Dimethicone, 2.7%

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

Purpose

Skin protectant

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 120oF

Do not use on:

• deep or puncture wounds
• animal bites
• serious burns
• keep out of reach of children

Directions

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

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

Derma Shield 2oz Aerosol USA

Derma Shield 6oz Aerosol USA

Derma Shield 17oz Aerosol USA

INGREDIENTS AND APPEARANCE

BENCHMARKS DERMA SHIELD 
dimethicone aerosol

Product 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)