SIMPLY FIRM - BODY GELCREME- dimethicone gel

Simply Firm - Body by

Drug Labeling and Warnings

Simply Firm - Body 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 Ingredients...........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 irritaed skin

When using this product

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

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
• any of these severe effects occur; allergic reaction, irritation becomes severe i.e. persistent 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 to 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, almond Oil, L-Carnitine, DMAE, Bitartrate, Sodium Ascorbyl Fosphate,, Sunflower Seed Oil, Green Tea extract, Coffee extract, Sodium Dodecyl Sulphate, Base Lemon Grass, Pepermint Oil, Menthol, Ultrex 21, Green Tea scent, EDTA, BHT, BHA.

DOSAGE & ADMINISTRATION

8 fl oz / 240 fl ml

PRINCIPAL DISPLAY PANEL

Simply Firm Body - GelcremeSkin and tissue firming

INGREDIENTS AND APPEARANCE

SIMPLY FIRM - BODY  GELCREME
dimethicone gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51439-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O)	Dimethicone	.0024 mg  in .024 mg

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
CETYL ALCOHOL (UNII: 936JST6JCN)
CETEARETH-12 (UNII: 7V4MR24V5P)
ALMOND OIL (UNII: 66YXD4DKO9)
LEVOCARNITINE (UNII: 0G389FZZ9M)
DEANOL (UNII: 2N6K9DRA24)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
SUNFLOWER OIL (UNII: 3W1JG795YI)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED)
TROLAMINE (UNII: 9O3K93S3TK)
SODIUM DODECYLBENZENESULFONATE (UNII: 554127163Y)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
PEPPERMINT OIL (UNII: AV092KU4JH)
MINT (UNII: FV98Z8GITP)
ALMOND (UNII: 3Z252A2K9G)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
EDETIC ACID (UNII: 9G34HU7RV0)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51439-003-01	.024 mg in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	08/05/2012

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

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

Establishment
Name	Address	ID/FEI	Business Operations
CarePluss Pharma S.A. de C.V.		815061551	manufacture(51439-003)