SIMPLY FIRM - BODY GELCREME- dimethicone gel 
CarePluss Pharma S.A. de C.V.

Disclaimer: 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.

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

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

Uses: protects from minor skin irritations.

Warnings: For external use only


Do not use


When using this product


Stop use and ask a doctor if:

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

Directions:

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
Document Id: 1ad3a24f-b2cb-4189-aa4c-b4670bc8d657
Set id: 3259fef2-b2e2-40aa-b383-601d65e982c4
Version: 4
Effective Time: 20130423
 
CarePluss Pharma S.A. de C.V.