TOPCARE SINUS SEVERE- oxymetazoline hydrochloride spray

topcare sinus severe by

Drug Labeling and Warnings

topcare sinus severe by is a Otc medication manufactured, distributed, or labeled by Topco Associates LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Oxymetazoline HCl 0.05%

Purpose

Nasal decongestant

Uses

temporarily relieves

• nasal congestion due to a cold, hay fever, or other upper respiratory allergies
• sinus congestion and pressure

Warnings

Ask a doctor before use if you have

• heart disease
• thyroid disease
• diabetes
• high blood pressure
• trouble urinating due to an enlarged prostate gland

When using this product

• do not exceed recommended dosage
• do not use this product for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.
• temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may occur
• use of this container by more than one person may spread infection

Stop use and ask a doctor if

• symptoms persist

If pregnant or breast feeding,

ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

Shake well before use. Remove protective cap. Before using for the first time, prime the pump by firmly depressing its rim several times. Hold container with thumb at base and nozzle between first and second fingers. Without tilting your head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and inhale deeply.

• adults & children 6 yrs. & older (with adult supervision):

  2 or 3 sprays in each nostril, not

  more often than every 10 to 12 hours.

  Do not exceed 2 doses in 24 hours.

• children 2 to under 6 yrs.:

  ask a doctor

• children under 2 yrs.:

  do not use

Other information

• store at 20-25°C (68-77°F)

Inactive ingredients

benzalkonium chloride solution, benzyl alcohol, camphor, dibasic sodium

phosphate, edetate disodium, eucalyptol, menthol, microcrystalline cellulose and

carboxymethylcellulose sodium, monobasic sodium phosphate, polyethylene glycol, povidone, propylene glycol, purified water

Questions or comments?

1-888-423-0139

Package/Label Principal Display Panel

WITH MENTHOL

Sinus Severe

OXYMETAZOLINE HCl 0.05%

NASAL DECONGESTANT

12 Hour Relief

Ultra Fine Mist

Sinus congestion & pressure

Fast & powerful relief

QUALITY GUARANTEED

COMPARE TO SINEX® SEVERE active ingredient

1 FL OZ (30 mL)

INGREDIENTS AND APPEARANCE

TOPCARE SINUS SEVERE 
oxymetazoline hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-607
Route of Administration	NASAL

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
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
EDETATE DISODIUM (UNII: 7FLD91C86K)
EUCALYPTOL (UNII: RV6J6604TK)
MENTHOL (UNII: L7T10EIP3A)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
POVIDONE (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
1	NDC: 36800-607-10	1 in 1 CARTON	11/06/2017
1		30 mL in 1 BOTTLE; 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	11/06/2017

Labeler - Topco Associates LLC (006935977)