NDC Code(s) : 68754-209-00
Packager : American Spraytech, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Dermoplast Anesthetic Pain Relieving AntibacterialBENZOCAINE, MENTHOL SPRAY
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68754-209
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOCAINE(UNII: U3RSY48JW5)
(BENZOCAINE - UNII:U3RSY48JW5) 		BENZOCAINE200 mg in 1 g
MENTHOL(UNII: L7T10EIP3A)
(MENTHOL - UNII:L7T10EIP3A) 		MENTHOL5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
ACETYLATED LANOLIN ALCOHOLS(UNII: SNN716810P)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
BUTANE(UNII: 6LV4FOR43R)
CETYL ACETATE(UNII: 4Q43814HXS)
1,1-DIFLUOROETHANE(UNII: 0B1U8K2ME0)
METHYLPARABEN(UNII: A2I8C7HI9T)
POLYSORBATE 85(UNII: A7F3N56197)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68754-209-0078 g in 1 BOX Type 0: Not a Combination Product27/12/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 12/26/2017

PRINCIPAL DISPLAY PANEL

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