Dolgencorp, LLC Clear Time™ Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

DG HEALTH CLEAR TIME- oxymetazoline hydrochloride spray 
Dolgencorp, 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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Dolgencorp, 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?

1-888-309-9030

Package/Label Principal Display Panel

Compare to active ingredient of QlearQuil® 12 Hour Nasal Decongestant

Non-Drowsy

Clear Time™

12 Hour

Nasal Decongestant

Oxymetazoline HCl 0.05%

Fast acting

Cold & allergy congestion

Sinus pressure

12 HOUR

Ultra Fine Mist

½ FL OZ (15mL)

DG HEALTH CLEAR TIME 
oxymetazoline hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55910-019
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
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
Color	WHITE (off-white)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55910-019-05	1 in 1 CARTON	05/01/2015	08/19/2019
1		15 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	05/01/2015	08/19/2019

Labeler - Dolgencorp, LLC (068331990)

Revised: 8/2019

Document Id: ce954dd8-47ce-4c9d-9f31-9ad3fd990221

34390-5

Set id: f7d03548-9a33-450e-bc00-725f269b1549

Version: 2

Effective Time: 20190822