NDC Code(s) : 68712-007-01, 68712-007-02, 68712-007-03, 68712-007-04
Packager : Innocutis Holdings LLC

Category : PRESCRIPTION MEDICAL DEVICE LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Bionect
Product Information
Product Type PRESCRIPTION MEDICAL DEVICE Item Code (Source) NDC:68712-007
Route of Administration DEA Schedule
Inactive Ingredients
Ingredient Name Strength
HYALURONIC ACID(UNII: S270N0TRQY).2 g in 1 g
PEG-8 STEARATE(UNII: 2P9L47VI5E)
DECYL OLEATE(UNII: ZGR06DO97T)
WHITE WAX(UNII: 7G1J5DA97F)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
SORBITOL(UNII: 506T60A25R)
SODIUM DEHYDROACETATE(UNII: 8W46YN971G)
METHYLPARABEN(UNII: A2I8C7HI9T)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68712-007-013 g in 1 TUBE
2NDC:68712-007-0225 g in 1 TUBE
3NDC:68712-007-0350 g in 1 TUBE
4NDC:68712-007-04100 g in 1 PACKAGE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
premarket notification K963004 04/01/2004

LABELER - Innocutis Holdings LLC(451549861)

PRINCIPAL DISPLAY PANEL

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