NDC Code(s) : 70996-001-01
Packager : Floratech Botanicals, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Blister BalmMENTHOL SALVE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70996-001
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL(UNII: L7T10EIP3A)
(MENTHOL - UNII:L7T10EIP3A) 		MENTHOL1.1 g in 100 g
Inactive Ingredients
Ingredient Name Strength
CLOVE LEAF OIL(UNII: VCA5491KVF)
PELARGONIUM ROSEUM OIL(UNII: XSN2Q85DC6)
PEPPERMINT OIL(UNII: AV092KU4JH)
EUCALYPTUS GLOBULUS LEAF(UNII: S546YLW6E6)
HYDROLYZED JOJOBA ESTERS (ACID FORM)(UNII: UDR641JW8W)
LEMON BALM OIL(UNII: MJ76269K9S)
ALPROSTADIL ISOPROPYL ESTER(UNII: 8THV3YDD6A)
CAMPHOR OIL(UNII: 75IZZ8Y727)
HYDROGENATED JOJOBA OIL(UNII: 7F674YQ5SO)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70996-001-010.9 g in 1 TUBE Type 0: Not a Combination Product18/10/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 10/18/2016

PRINCIPAL DISPLAY PANEL

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