BENCHMARKS DERMA SHIELD- dimethicone aerosol
Fillcare Limited

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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Active Ingredient

Dimethicone, 2.7%

Purpose

Skin protectant

Keep Out of Reach of Children

Do not use on:

deep or puncture wounds
animal bites
serious bites

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

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 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 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

Derma Shield 2 oz Aerosol

BENCHMARKS DERMA SHIELD
dimethicone aerosol

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69881-003
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	2.7 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69881-003-01	57 g in 1 BOTTLE; Type 0: Not a Combination Product	03/23/2016	04/01/2023

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

Labeler - Fillcare Limited (227632171)

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

Revised: 6/2018

Document Id: 6f7de4d2-9f83-b465-e053-2991aa0ac9b3

Set id: 2eb88fe4-004e-6c2e-e054-00144ff8d46c

Version: 4

Effective Time: 20180625

Fillcare Limited