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 Delta Kits Inc. 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

Do not use on:

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

INDICATIONS & USAGE

Uses

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

DOSAGE & ADMINISTRATION

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" size amount in palm
• Rub thoroughly onto the skin
• Alllow to dry

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BENCHMARKS DERMA SHIELD 
dimethicone aerosol

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70557-002
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70557-002-02	170 g in 1 CAN; Type 0: Not a Combination Product	04/27/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	04/27/2016

Labeler - Delta Kits Inc (180476731)