ZICAM- oxymetazoline hydrochloride spray 
Matrixx Initiatives, Inc.

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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ZICAM®
EXTREME
Congestion
Relief

Drug Facts

Active ingredient

Oxymetazoline HCl 0.05%

Purpose

Nasal decongestant

Uses

  • temporarily relieves nasal congestion due to:
    • common cold
    • hay fever
    • upper respiratory allergies
  • helps clear nasal passages.
  • shrinks swollen membranes.
  • temporarily relieves sinus congestion and pressure.

Warnings

For nasal use only.

Ask a doctor before use if you have

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

When using this product

  • Do not use more than directed.
  • Do not use 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 result.
  • Use of this container by more than 1 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.

Directions

  • Adults and children 6-12 years of age (with adult supervision):
    Pump 2 or 3 times in each nostril without tilting your head. Sniff deeply. Wipe nozzle clean after use.
  • Do not use more often than once every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
  • Children under 6 years of age: Consult a doctor before use.

To use pump:

  • Remove cap and safety clip.
  • Hold with thumb at bottom of bottle and nozzle between fingers.
  • Before using the first time, prime pump by depressing several times.

Inactive ingredients

alkoxylated diester, aloe barbadensis gel, benzalkonium chloride, benzyl alcohol, disodium EDTA, disodium phosphate, glycerin, hydroxyethylcellulose, hydroxylated lecithin, monosodium phosphate, purified water

Store at room temperature 15°C-29°C (59°F-84°F)

Questions? Comments?
Side Effects?

call 877-942-2626 toll free or
visit us on the web at
www.zicam.com

PRINCIPAL DISPLAY PANEL - 22.5 mL Bottle Carton

NDC 62750-005-11

ZICAM®

50% MORE FREE!

EXTREME
Congestion
Relief

Nasal Decongestant
Oxymetazoline HCl

FAST RELIEF OF:

  • NASAL CONGESTION
  • SINUS PRESSURE

With Soothing
ALOE VERA

12
HOUR
LONG LASTING
PATENTED FORMULA

0.75 FL. OZ./22.5mL

Non-Drowsy

Principal Display Panel - 22.5 mL Bottle Carton
ZICAM 
oxymetazoline hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62750-005
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
oxymetazoline Hydrochloride (UNII: K89MJ0S5VY) (oxymetazoline - UNII:8VLN5B44ZY) oxymetazoline Hydrochloride0.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
benzalkonium chloride (UNII: F5UM2KM3W7)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62750-005-111 in 1 CARTON07/01/201009/15/2017
122.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/01/201009/15/2017
Labeler - Matrixx Initiatives, Inc. (790037253)

Revised: 10/2017
Document Id: 25236ca4-7e00-4856-b327-05873c8b4061
Set id: 3260b418-0ff7-4b2a-9824-215b2e7682d8
Version: 2
Effective Time: 20171002
 
Matrixx Initiatives, Inc.