TOPCARE CLEAR TIME- oxymetazoline hydrochloride spray 
Topco Associates LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Topco Associates LLC. Clear Time™ Drug Facts

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

Unlock pump and remove protective cap. Shake well before use. 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. Lock pump to maintain child resistance.

Adults and children 6 years and 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 any 24-hour period

Children 2 to under 6 years:

ask a doctor

Children under 2 years:

do not use

Other information

•
store at 20-25°C (68-77°F)

Inactive ingredients

benzalkonium chloride solution, benzyl alcohol, dibasic sodium phosphate, edetate disodium, microcrystalline cellulose and carboxymethylcellulose sodium, monobasic sodium phosphate, polyethylene glycol, povidone, purified water

Questions or comments?

1-888-423-0139

Package/Label Principal Display Panel

12 HR NASAL DECONGESTANT

Clear Time™

NASAL DECONGESTANT

OXYMETAZOLINE HCl 0.05%

Fast acting

Cold & allergy congestion

Sinus pressure

Non-drowsy

Ultra Fine Mist

COMPARE TO QLEARQUIL® 12 HOUR NASAL DECONGESTANT active ingredient

½ FL OZ (15 mL)

Topcare Clear Time Image 1
Topcare Clear Time Image 2

TOPCARE CLEAR TIME 
oxymetazoline hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-559
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE.05 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorWHITE (off-white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-559-051 in 1 CARTON06/29/201506/17/2019
115 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/29/201506/17/2019
Labeler - Topco Associates LLC (006935977)

Revised: 8/2019
Document Id: 19705f0f-85d5-469e-9af3-77a20699f1d6
Set id: 873084e4-e280-459d-9ea3-6b47f3a9f1f5
Version: 2
Effective Time: 20190822
 
Topco Associates LLC