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

Edge by

Drug Labeling and Warnings

Edge by is a Otc medication manufactured, distributed, or labeled by Aloe Vera Industries Pty Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Inactive Ingredients

Purified water, Hydroxypropyl starch phosphate,

Jojoba oil, Dicaprylyl ether, Gluconodeltalactone,

Xanthan gum, Sodium stearoyl glutamate, Sodium

benzoate, Citric acid

PURPOSE

Delay gel for men

WARNINGS

Warnings: For external use only. Avoid Contact with eyes

INDICATIONS & USAGE

Uses: Helps in the preventions of premature ejaculation

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

KEEP OUT OF REACH OF CHILDREN.

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

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 gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 29558-001
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: 29558-001-01	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 - Aloe Vera Industries Pty Ltd (758970461)

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