Label: EDGE- gambir, mucuna pruriens seed, erythroxylum catuaba bark, epimedium grandiflorum top, turnera diffusa leaf, ginkgo, eleuthero, panax notoginseng root,tribulus terrestris fruit gel
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Contains inactivated NDC Code(s)
NDC Code(s): 69768-001-01 - Packager: Sensuous Pty Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated April 17, 2015
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Active Ingredients
Uncaria Gambir 2.000 mg/g
Mucuna pruriens seed 0.025 mg/g
Erythroxylum catuaba bark 0.025 mg/g
Epimedium grandiflorum leaf 0.012 mg/g
Turnera diffusa leaf 0.124 mg/g
Ginkgo Biloba leaf 0.124 mg/g
Eluetherococcus senticosus root 0.124 mg/g
Panax notoginseng root 0.018 mg/g
Tribulus terrestris fruit 0.124 mg/g
- INACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- INDICATIONS & USAGE
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STOP USE
Discontinue Use and Consult a Doctor if:
This product used as directed does not provide
relief. Premature ejaculation may be due to a condition
requiring medical supervision.
You or your partner may develop a rash or irritation, such
as itching or burning.
If swallowed, seek medical assistance or contact
a Poison Control Center immediately.
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
Edge is a topical gel. Apply a very small amount
of Edge onto the tip of your finger.
Gently massage the gel onto the head
(glans) of your penis and leave to air dry for
a few minutes.
You should start to feel a tingling sensation in about
30 to 40 minutes and the product should be fully effective
in about an hour.
Its potency will last several hours which means Edge can be
applied long before any sexual contact. This also means that
you and your partner can enjoy uninterrupted sex without
spoiling the moment.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
EDGE
gambir, mucuna pruriens seed, erythroxylum catuaba bark, epimedium grandiflorum top, turnera diffusa leaf, ginkgo, eleuthero, panax notoginseng root,tribulus terrestris fruit gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69768-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GAMBIR (UNII: 3NJQ5D8S6N) (GAMBIR - UNII:3NJQ5D8S6N) GAMBIR 2 mg in 1 g MUCUNA PRURIENS SEED (UNII: 55G8SQ543S) (MUCUNA PRURIENS SEED - UNII:55G8SQ543S) MUCUNA PRURIENS SEED .025 mg in 1 g ERYTHROXYLUM CATUABA BARK (UNII: 3W8LSF0XRN) (ERYTHROXYLUM CATUABA BARK - UNII:3W8LSF0XRN) ERYTHROXYLUM CATUABA BARK .025 mg in 1 g EPIMEDIUM GRANDIFLORUM TOP (UNII: 137PC46F89) (EPIMEDIUM GRANDIFLORUM TOP - UNII:137PC46F89) EPIMEDIUM GRANDIFLORUM TOP .012 mg in 1 g TURNERA DIFFUSA LEAF (UNII: 812R0W1I3K) (TURNERA DIFFUSA LEAF - UNII:812R0W1I3K) TURNERA DIFFUSA LEAF .124 mg in 1 g GINKGO (UNII: 19FUJ2C58T) (GINKGO - UNII:19FUJ2C58T) GINKGO .124 mg in 1 g ELEUTHERO (UNII: ZQH6VH092Z) (ELEUTHERO - UNII:ZQH6VH092Z) ELEUTHERO .124 mg in 1 g PANAX NOTOGINSENG ROOT (UNII: GQX1C1175U) (PANAX NOTOGINSENG ROOT - UNII:GQX1C1175U) PANAX NOTOGINSENG ROOT .018 mg in 1 g TRIBULUS TERRESTRIS FRUIT (UNII: QNL076V6EQ) (TRIBULUS TERRESTRIS FRUIT - UNII:QNL076V6EQ) TRIBULUS TERRESTRIS FRUIT .124 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) JOJOBA OIL (UNII: 724GKU717M) DICAPRYLYL ETHER (UNII: 77JZM5516Z) GLUCONOLACTONE (UNII: WQ29KQ9POT) XANTHAN GUM (UNII: TTV12P4NEE) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) SODIUM BENZOATE (UNII: OJ245FE5EU) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69768-001-01 1 in 1 CARTON 1 7 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 04/01/2015 Labeler - Sensuous Pty Ltd (750985793)
