NDC 69768-001

Edge

Gambir, Mucuna Pruriens Seed, Erythroxylum Catuaba Bark, Epimedium Grandiflorum Top, Turnera Diffusa Leaf, Ginkgo, Eleuthero, Panax Notoginseng Root,tribulus Terrestris Fruit

Edge is a Topical Gel in the Human Otc Drug category. It is labeled and distributed by Sensuous Pty Ltd. The primary component is Gambir; Mucuna Pruriens Seed; Erythroxylum Catuaba Bark; Epimedium Grandiflorum Top; Turnera Diffusa Leaf; Ginkgo; Eleuthero; Panax Notoginseng Root; Tribulus Terrestris Fruit.

• Product ID: 69768-001_84308edf-c37e-47d2-ad44-5e2b55eb5fcc
• NDC: 69768-001
• Product Type: Human Otc Drug
• Proprietary Name: Edge
• Generic Name: Gambir, Mucuna Pruriens Seed, Erythroxylum Catuaba Bark, Epimedium Grandiflorum Top, Turnera Diffusa Leaf, Ginkgo, Eleuthero, Panax Notoginseng Root,tribulus Terrestris Fruit
• Dosage Form: Gel
• Route of Administration: TOPICAL
• Marketing Start Date: 2015-04-01
• Marketing Category: UNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
• Labeler Name: Sensuous Pty Ltd
• Substance Name: GAMBIR; MUCUNA PRURIENS SEED; ERYTHROXYLUM CATUABA BARK; EPIMEDIUM GRANDIFLORUM TOP; TURNERA DIFFUSA LEAF; GINKGO; ELEUTHERO; PANAX NOTOGINSENG ROOT; TRIBULUS TERRESTRIS FRUIT
• Active Ingredient Strength: 2 mg/g; mg/g; mg/g; mg/g; mg/g; mg/g; mg/g; mg/g; mg/g
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 69768-001-01

1 TUBE in 1 CARTON (69768-001-01) > 7 g in 1 TUBE

• Marketing Start Date: 2015-04-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69768-001-01 [69768000101]

Edge GEL

• Marketing Category: unapproved drug other
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2015-04-01
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
GAMBIR	2 mg/g

OpenFDA Data

• SPL SET ID: c5193062-72c5-424f-b18a-5cc75677c76b
• Manufacturer:
  • Sensuous Pty Ltd
• UNII:
  • 3W8LSF0XRN
  • 55G8SQ543S
  • 137PC46F89
  • ZQH6VH092Z
  • QNL076V6EQ
  • 812R0W1I3K
  • GQX1C1175U
  • 3NJQ5D8S6N
  • 19FUJ2C58T

NDC Crossover Matching brand name "Edge" or generic name "Gambir, Mucuna Pruriens Seed, Erythroxylum Catuaba Bark, Epimedium Grandiflorum Top, Turnera Diffusa Leaf, Ginkgo, Eleuthero, Panax Notoginseng Root,tribulus Terrestris Fruit"

NDC	Brand Name	Generic Name
29558-001	Edge	GAMBIR, MUCUNA PRURIENS SEED, ERYTHROXYLUM CATUABA BARK, EPIMEDIUM GRANDIFLORUM TOP, TURNERA DIFFUSA LEAF, GINKGO, ELEUTHERO, PANAX NOTOGINSENG ROOT,TRIBULUS TERRESTRIS FRUIT
42421-018	Edge	ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY
42421-020	Edge	ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY
42421-022	Edge	ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY
69768-001	Edge	GAMBIR, MUCUNA PRURIENS SEED, ERYTHROXYLUM CATUABA BARK, EPIMEDIUM GRANDIFLORUM TOP, TURNERA DIFFUSA LEAF, GINKGO, ELEUTHERO, PANAX NOTOGINSENG ROOT,TRIBULUS TERRESTRIS FRUIT