Label: SIMPLY FIRM EYE - NON-SURGICAL FACE LIFT- dimethicone gel gel
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Contains inactivated NDC Code(s)
NDC Code(s): 51439-001-01 - Packager: CarePluss Pharma S.A. de C.V.
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated April 23, 2013
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- ACTIVE INGREDIENT
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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
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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 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
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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
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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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SIMPLY FIRM EYE - NON-SURGICAL FACE LIFT
dimethicone gel gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51439-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 0.6 mg in 60 mg Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALMOND OIL (UNII: 66YXD4DKO9) 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) COCONUT (UNII: 3RT3536DHY) LIME (CITRUS) (UNII: 8CZS546954) EDETIC ACID (UNII: 9G34HU7RV0) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) SUNFLOWER OIL (UNII: 3W1JG795YI) VITIS VINIFERA SEED (UNII: C34U15ICXA) 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:51439-001-01 60 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(51439-001)
