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 - Gelcreme Skin and tissue firming
SIMPLY FIRM - BODY  GELCREME
dimethicone gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51439-003
Route of Administration TOPICAL DEA Schedule     
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)

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.