Edge: Package Insert and Label Information

EDGE — gambir, mucuna pruriens seed, erythroxylum catuaba bark , epimedium grandiflorum top, turnera diffusa leaf, ginkgo, eleuthero, panax notoginseng root and 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.

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.

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 Type HUMAN OTC DRUG Item Code (Source) NDC:29558-001 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GAMBIR (GAMBIR) GAMBIR 2 mg in 1 g MUCUNA PRURIENS SEED (MUCUNA PRURIENS SEED) MUCUNA PRURIENS SEED .025 mg in 1 g ERYTHROXYLUM CATUABA BARK (ERYTHROXYLUM CATUABA BARK ) ERYTHROXYLUM CATUABA BARK .025 mg in 1 g EPIMEDIUM GRANDIFLORUM TOP (EPIMEDIUM GRANDIFLORUM TOP) EPIMEDIUM GRANDIFLORUM TOP .012 mg in 1 g TURNERA DIFFUSA LEAF (TURNERA DIFFUSA LEAF) TURNERA DIFFUSA LEAF .124 mg in 1 g GINKGO (GINKGO) GINKGO .124 mg in 1 g ELEUTHERO (ELEUTHERO) ELEUTHERO .124 mg in 1 g PANAX NOTOGINSENG ROOT (PANAX NOTOGINSENG ROOT) PANAX NOTOGINSENG ROOT .018 mg in 1 g TRIBULUS TERRESTRIS FRUIT (TRIBULUS TERRESTRIS FRUIT) TRIBULUS TERRESTRIS FRUIT .124 mg in 1 g

Inactive Ingredients Ingredient Name Strength WATER JOJOBA OIL DICAPRYLYL ETHER GLUCONOLACTONE XANTHAN GUM SODIUM STEAROYL GLUTAMATE SODIUM BENZOATE CITRIC ACID MONOHYDRATE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:29558-001-01 1 TUBE in 1 CARTON contains a TUBE 1 7 g in 1 TUBE This package is contained within the CARTON (29558-001-01)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 04/01/2015

Labeler — Aloe Vera Industries Pty Ltd (758970461)

Establishment
Name	Address	ID/FEI	Operations
Aloe Vera Industries Pty Ltd		758970461	manufacture (29558-001)

Revised: 04/2015 Aloe Vera Industries Pty Ltd