EDGE - gambir, mucuna pruriens seed, erythroxylum catuaba bark, epimedium grandiflorum top, turnera diffusa leaf, ginkgo, eleuthero, panax notoginseng root,tribulus terrestris fruit  gel 
Aloe Vera Industries Pty Ltd

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.

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Drug Facts

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 Ingredients

Purified water, Hydroxypropyl starch phosphate,

Jojoba oil, Dicaprylyl ether, Gluconodeltalactone,

Xanthan gum, Sodium stearoyl glutamate, Sodium

benzoate, Citric acid

Delay gel for men

Warnings: For external use only. Avoid Contact with eyes


Uses: Helps in the preventions of premature ejaculation


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.

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.

copy of label

EDGE 
gambir, mucuna pruriens seed, erythroxylum catuaba bark, epimedium grandiflorum top, turnera diffusa leaf, ginkgo, eleuthero, panax notoginseng root,tribulus terrestris fruit gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29558-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GAMBIR (UNII: 3NJQ5D8S6N) (GAMBIR - UNII:3NJQ5D8S6N) GAMBIR2 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 NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:29558-001-011 in 1 CARTON
17 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/01/2015
Labeler - Aloe Vera Industries Pty Ltd (758970461)
Establishment
NameAddressID/FEIBusiness Operations
Aloe Vera Industries Pty Ltd758970461manufacture(29558-001)

Revised: 4/2015
Document Id: 46c996c7-1eae-45dc-90b3-9cfc39f2fe49
Set id: eb0b76a4-7453-473c-b41b-659e0ecbf48d
Version: 2
Effective Time: 20150416
 
Aloe Vera Industries Pty Ltd