NDC Code(s) : 42507-037-10
Packager : HyVee Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

NasalOxymetazoline hydrochloride SPRAY
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42507-037
Route of Administration NASAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYMETAZOLINE HYDROCHLORIDE(UNII: K89MJ0S5VY)
(OXYMETAZOLINE - UNII:8VLN5B44ZY) 		OXYMETAZOLINE HYDROCHLORIDE.05 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL(UNII: LKG8494WBH)
SODIUM PHOSPHATE, DIBASIC(UNII: GR686LBA74)
EDETATE DISODIUM(UNII: 7FLD91C86K)
EUCALYPTOL(UNII: RV6J6604TK)
MENTHOL, UNSPECIFIED FORM(UNII: L7T10EIP3A)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM(UNII: K679OBS311)
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM(UNII: 3980JIH2SW)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
POVIDONES(UNII: FZ989GH94E)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
WATER(UNII: 059QF0KO0R)
Product Characteristics
Color WHITE (off white) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42507-037-101 in 1 CARTON 08/12/2016
130 mL in 1 BOTTLE, PUMP Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 08/12/2016

PRINCIPAL DISPLAY PANEL

COMPARE TO the Active Ingredient of Afrin® No Drip

Maximum Strength

Plus Menthol

Nasal

Spray

Oxymetazoline HCl 0.05%

Nasal Decongestant

Severe Congestion

No Drip

12 Hour Relief

Pump Mist

Won’t Drip From Nose or Down Throat

Fast, Powerful Congestion Relief

For Colds & Allergies

1 FL OZ

(30 mL)

Nasal Spray Carton Image 1Nasal Spray Carton Image 1