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 Fillcare Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Dimethicone, 2.7%

PURPOSE

Purpose

Skin protectant

KEEP OUT OF REACH OF CHILDREN

Keep Out of Reach of Children

Do not use on:

• deep or puncture wounds
• animal bites
• serious bites

INDICATIONS & USAGE

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

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 & ADMINISTRATION

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 INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BENCHMARKS DERMA SHIELD 
dimethicone aerosol

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69881-003
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
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
BUTANE (UNII: 6LV4FOR43R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
GLYCERIN (UNII: PDC6A3C0OX)
ISOBUTANE (UNII: BXR49TP611)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
LANOLIN (UNII: 7EV65EAW6H)
METHYLPARABEN (UNII: A2I8C7HI9T)
PALM KERNEL ACID (UNII: 79P21R4317)
PALMITIC ACID (UNII: 2V16EO95H1)
PERFLUOROPOLYMETHYLISOPROPYL ETHER (UNII: X6324K3MBW)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPANE (UNII: T75W9911L6)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM BENZOATE (UNII: OJ245FE5EU)
EDETATE SODIUM (UNII: MP1J8420LU)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
COPOVIDONE K25-31 (UNII: D9C330MD8B)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69881-003-02	170 g in 1 BOTTLE; Type 0: Not a Combination Product	03/23/2016	04/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	03/23/2016	04/01/2023

Labeler - Fillcare Limited (227632171)

Establishment
Name	Address	ID/FEI	Business Operations
Fillcare Limited		227632171	manufacture(69881-003)