Your browser does not support JavaScript! SIMPLY FIRM - BODY GELCREME (DIMETHICONE) GEL [CAREPLUSS PHARMA S.A. DE C.V.]
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SIMPLY FIRM - BODY GELCREME (dimethicone) gel
[CarePluss Pharma S.A. de C.V.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

Active Ingredients...........Purpose

Dimethicone 1%.............Skin Protectant

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: 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. If swallowed get medical help or contact a Poison Control Center immediately

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

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.

8 fl oz / 240 fl ml

label
Simply Firm Body - GelcremeSkin and tissue firming
SIMPLY FIRM - BODY  GELCREME
dimethicone gel
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:51439-003
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (Dimethicone) Dimethicone.0024 mg  in .024 mg
Inactive Ingredients
Ingredient NameStrength
Water 
Glycerin 
CETYL ALCOHOL 
CETEARETH-12 
ALMOND OIL 
LEVOCARNITINE 
DEANOL 
SODIUM ASCORBYL PHOSPHATE 
SUNFLOWER OIL 
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) 
WEST INDIAN LEMONGRASS OIL 
TROLAMINE 
SODIUM DODECYLBENZENESULFONATE 
ASCORBIC ACID 
PEPPERMINT OIL 
MINT 
ALMOND 
GREEN TEA LEAF 
EDETIC ACID 
METHYLPARABEN 
PROPYLPARABEN 
BUTYLATED HYDROXYTOLUENE 
BUTYLATED HYDROXYANISOLE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51439-003-01.024 mg in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34708/05/2012
Labeler - CarePluss Pharma S.A. de C.V. (815061551)
Registrant - CarePluss Pharma S.A. de C.V. (815061551)
Establishment
NameAddressID/FEIBusiness Operations
CarePluss Pharma S.A. de C.V.815061551manufacture(51439-003)

Revised: 4/2013
 
CarePluss Pharma S.A. de C.V.

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