SIMPLY FIRM - FACE AND NECK NON SURGICAL FACE LIFT- dimethicone gel

Simply Firm - Face and Neck by

Drug Labeling and Warnings

Simply Firm - Face and Neck by is a Otc medication manufactured, distributed, or labeled by CarePluss Pharma S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient                      Purpose

Dimethicone 1% ............. skin protectant

PURPOSE

Uses: protects from minor skin irritations.

• temporarily protects injured or exposed skin
• slows the loss of water of the skin by forming a barrier on the skin's surface
• enhances the appearance of dry or damaged skin
• increases the water content of the top layers of the skin
• is a lubricant for the surface of the skin
• gives skin a soft and smooth appearance

WARNINGS

Warnings: For external use only

• when using this product skin irritation may occur
• some medicines may interact with dimethicone, however, no specific interactions are known at this time

Do not use

• if you are allergic to any ingredients listed
• if you have sensitive skin and/or are sensitive to Dimethicone
• do not use if you are pregnant, planning to become pregnant, or breast feeding
• if you have an open wound, burn, damaged or irritated skin

When using this product

• skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling
• should irritation occur lessen frequency of use
• avoid unnecessary sun exposure and use a 45 SPF sun screen when going outside

Stop use and ask a doctor

• if any of these severe side effects occur: allergic reaction, irritation become severe i.e. persistant rash, hives, itching, burning, difficulty breathing, swelling

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center immediately.

INDICATIONS & USAGE

Directions:

• cleanse gently
• apply SIMPLY FIRM BODY
• massage into desired area using long upward strokes
• start with a single application, gradually increase to as many applications as desired
• when going outside be sure to use a 45 SPF SUN SCREEN applicable to the area
• if excessive irritation or sensitivity develops stop use of product and contact a physician

INACTIVE INGREDIENT

Other ingredients: Water, Almond Oil, Glycerin, Cetearyl alcohol, Cetearteh-12, Mineral Oil, L-Carnitine, DMAE bitartrate, Sodium Ascorbyl Fosphate, Carbomer, Green Tea extract, Coffe Berry extract, Trietanolamine, Sodium Lauryl Sulphate, Vitamin C, Pepermint Oil, Menthol, Almond scent, Green Tea scent, Coco scent, EDTA disodium.

DOSAGE & ADMINISTRATION

3 fl oz / 119 mL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SIMPLY FIRM - FACE AND NECK  NON SURGICAL FACE LIFT
dimethicone gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51439-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	.00119 mg  in .119 mg

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ALCOHOL (UNII: 936JST6JCN)
CETEARETH-12 (UNII: 7V4MR24V5P)
MINERAL OIL (UNII: T5L8T28FGP)
LEVOCARNITINE (UNII: 0G389FZZ9M)
DEANOL (UNII: 2N6K9DRA24)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
COFFEE BEAN (UNII: JFH385Y744)
TROLAMINE (UNII: 9O3K93S3TK)
SODIUM DODECYLBENZENESULFONATE (UNII: 554127163Y)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
PEPPERMINT OIL (UNII: AV092KU4JH)
MINT (UNII: FV98Z8GITP)
ALMOND (UNII: 3Z252A2K9G)
MELISSA OFFICINALIS (UNII: YF70189L0N)
COCOA (UNII: D9108TZ9KG)
EDETIC ACID (UNII: 9G34HU7RV0)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
SUNFLOWER OIL (UNII: 3W1JG795YI)
WATER (UNII: 059QF0KO0R)
POMEGRANATE SEED OIL (UNII: 0UI45XV0T6)
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51439-002-01	.119 mg in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	06/27/2012

Labeler - CarePluss Pharma S.A. de C.V. (815061551)

Establishment
Name	Address	ID/FEI	Business Operations
CarePluss Pharma S.A. de C.V.		815061551	manufacture(51439-002)