NDC Code(s) : 37808-817-10
Packager : H E B

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

rx act nasal oxymetazoline hydrochloride SPRAY
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:37808-817
Route of Administration NASAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYMETAZOLINE HYDROCHLORIDE(UNII: K89MJ0S5VY)
(OXYMETAZOLINE - UNII:8VLN5B44ZY) 		OXYMETAZOLINE HYDROCHLORIDE0.05 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL(UNII: LKG8494WBH)
EDETATE DISODIUM(UNII: 7FLD91C86K)
EUCALYPTOL(UNII: RV6J6604TK)
MENTHOL(UNII: L7T10EIP3A)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
WATER(UNII: 059QF0KO0R)
SODIUM PHOSPHATE, DIBASIC(UNII: GR686LBA74)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS(UNII: KH7I04HPUU)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:37808-817-101 in 1 CARTON
130 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 08/25/2000

PRINCIPAL DISPLAY PANEL

Compare to Afrin® Sinus Nasal Spray active ingredient

NASAL SPRAY

Sinus

Oxymetazoline Hydrochloride 0.05%

12 Hour Nasal Decongestant

Fast, Powerful Congestion Relief

Relieves Painful Sinus Pressure

GLUTEN FREE

1 FL OZ (30 mL)

RX Act Nasal Spray Image 1RX Act Nasal Spray Image 1