ULTIMATE SKIN PROTECTANT DERMA SHIELD- dimethicone aerosol

Ultimate Skin Protectant Derma Shield by

Drug Labeling and Warnings

Ultimate Skin Protectant Derma Shield by is a Otc medication manufactured, distributed, or labeled by Fleet Laboratories LTD, FLEET LABORATORIES LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient Purpose

Dimethicone 2.7% Skin Protectant

PURPOSE

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

INDICATIONS & USAGE

Stop use and ask a doctor if:

• condition worsens
• symptoms last more than 7 days or clear up again within a few days

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°F

DOSAGE & ADMINISTRATION

Directions

• Apply as needed
• Children under 6 months: ask a doctor
• Wash and dry skin area
• Shake can vigourously
  • Invert can and apply "golf Ball" size amount 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, Perfluorianted Polyether, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Lanolin, Tetrasodium EDTA, Propylene Glycol Diazolidinyl Urea, Methylparaben, Propylparaben, Sodium Benzoate, Potassium Sorbate,Citric Acid.

PRINCIPAL DISPLAY PANEL

Benchmark's

DermaShield

The Ultimate Skin Protectant

Net Weight 17 oz(1lb 1 oz) (482g)

INGREDIENTS AND APPEARANCE

ULTIMATE SKIN PROTECTANT DERMA SHIELD 
dimethicone aerosol

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70233-010
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
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ISOBUTANE (UNII: BXR49TP611)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
EDETATE SODIUM (UNII: MP1J8420LU)
LANOLIN (UNII: 7EV65EAW6H)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
PALM KERNEL ACID (UNII: 79P21R4317)
COPOVIDONE K25-31 (UNII: D9C330MD8B)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM BENZOATE (UNII: OJ245FE5EU)
PALMITIC ACID (UNII: 2V16EO95H1)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
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: 70233-010-01	482 g in 1 CAN; Type 0: Not a Combination Product	10/14/2019
2	NDC: 70233-010-02	170 g in 1 CAN; Type 0: Not a Combination Product	10/14/2019
3	NDC: 70233-010-03	57 g in 1 CAN; Type 0: Not a Combination Product	10/14/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	10/14/2019

Labeler - Fleet Laboratories LTD (217269489)

Establishment
Name	Address	ID/FEI	Business Operations
FLEET LABORATORIES LTD		217269489	manufacture(70233-010)