MARLY SKIN GUARD- dimethicone aerosol, foam

Marly Skin Guard by

Drug Labeling and Warnings

Marly Skin Guard by is a Otc medication manufactured, distributed, or labeled by Marly Skin NA Inc, Marly Skin USA LLC, VEMA Industrie-Verpackung GmbH & Co. KG. Kontrakt - Abfüllung und -Verpackung. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients Dimethicone 1%

PURPOSE

Purpose Skin Protectant

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

INDICATIONS & USAGE

Uses

Temporarily protects and helps relieve chapped or cracked skin

Helps protect from the drying effects of wind and cold weather

WARNINGS

Warnings

Avoid spraying in eyes

Contents under pressure. Flammable. Do not puncture or incinerate. Do not store at temperatures above 120 F. Keep out of reach of children

Use only as directed

For external use only

Do not use

Do not use on puncture wounds, animal bites, serious burns

Stop Use and ask a doctor if

Condition worsens

Symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children

DOSAGE & ADMINISTRATION

Directions

Skin must be clean and dry. Shake well before use. Dispense the foam by pressing the application nozzle while holding can upside down. When applying to hands, a walnut size amount is enough. Good for the entire body. Gently rub the foam into the skin covering all areas for full effect. Allow 3 minutes to dry.

OTHER SAFETY INFORMATION

Other information

Distributed by Marly Skin USA LLC, 1209 Orange St. Wilmington, DE 19801

Made in Germany

Marly Skin Guard forms a two-dimensional skin barrier which helps protectthe skin against allergens, chemicals and toxins. Like an invisible glove. Helps prevent skin problems from incontinence, when wearing gloves and from frequent cleansing and sanitizing. Nongreasy. Skin breathes and perspires normally. Nontoxic and hypoallergenic. for terms and conditions visit: www.marlyskinguard.com

INACTIVE INGREDIENT

Inactive Ingredients

Water, Propane, Butane, TEA-Stearate, Sorbitol, Propylene Glycol, Glycerin, Methylparaben, Propylparaben, Aloe Barbadensis, tocopherol

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MARLY SKIN GUARD 
dimethicone aerosol, foam

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53633-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
PROPANE (UNII: T75W9911L6)
butane (UNII: 6LV4FOR43R)
TROLAMINE STEARATE (UNII: 1J6JM3JE61)
SORBITOL (UNII: 506T60A25R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
TOCOPHEROL (UNII: R0ZB2556P8)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53633-100-01	100 mL in 1 CAN; Type 0: Not a Combination Product	10/08/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	10/08/2012

Labeler - Marly Skin NA Inc (203259353)

Registrant - Marly Skin USA LLC (078623692)

Establishment
Name	Address	ID/FEI	Business Operations
VEMA Industrie-Verpackung GmbH & Co. KG. Kontrakt - Abfüllung und -Verpackung		316193515	manufacture(53633-100)