Zicam ®

Zicam ®
SPL v3
SPL
SPL Set ID d916f7ff-84b7-57ef-e053-2995a90a3efa
Route
NASAL
Published
Effective Date 2023-02-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oxymetazoline (0.5 mg)
Inactive Ingredients
Aloe Vera Leaf Benzalkonium Chloride Benzyl Alcohol Edetate Disodium Sodium Phosphate, Dibasic, Anhydrous .alpha.-tocopherol, Dl- Eucalyptol Glycerin Hydroxyethyl Cellulose (100 Mpa.s At 2%) Menthol, Unspecified Form Sodium Phosphate, Monobasic, Unspecified Form Polysorbate 80 Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-02-28

Description

Drug Facts

Purpose

Nasal decongestant


Medication Information

Purpose

Nasal decongestant

Description

Drug Facts

Uses
  • temporarily relieves nasal congestion due to:
    • the common cold
    • hay fever
    • upper respiratory allergies
  • temporarily relieves sinus congestion and pressure
  • helps clear nasal passages
  • shrinks swollen membranes
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor ifsymptoms persist

Section 53414-9

If pregnant or breast-feeding,ask a health professional before use.

Directions
  • adults and children 6 to under 12 years of age (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 under 6 years of age: ask a doctor

To use pump:

  • to open, hold the actuator to squeeze and turn cap
  • hold with thumb at bottom of bottle and nozzle between fingers
  • before using the first time, prime pump by depressing several times
  • place tip of nozzle just past nasal opening (approximately 1/8")
  • pump 2 or 3 times in each nostril without tilting your head. Sniff deeply.
  • wipe nozzle clean after use
  • to close, turn cap until it 'clicks'
Active Ingredient

Oxymetazoline hydrochloride 0.05%

Other Information
  • store between 15-29°C (59-84°F)
  • retain carton for future reference on full labeling
Inactive Ingredients

aloe barbadensis gel, benzalkonium chloride, benzyl alcohol, disodium EDTA, disodium phosphate, dl-alpha tocopherol, eucalyptol, glycerin, hydroxyethylcellulose, menthol, monosodium phosphate, polysorbate 80, purified water

Questions? Comments?

call 877-942-2626 toll free

www.zicam.com

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 one person may spread infection
Ask A Doctor Before Use If You Have
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
Principal Display Panel 15 Ml Bottle Carton

ZICAM ®

INTENSE

SINUS

RELIEF

OXYMETAZOLINE HCl 0.05%

NASAL DECONGESTANT

12

HOUR

RELIEF

COLDS*ALLERGIES

Maximum Strength

Relief of Sinus

Pressure

No-Drip Liquid ®

NASAL SPRAY

Cooling

Menthol & Eucalyptus

0.50 FL OZ (15 mL)


Structured Label Content

Uses
  • temporarily relieves nasal congestion due to:
    • the common cold
    • hay fever
    • upper respiratory allergies
  • temporarily relieves sinus congestion and pressure
  • helps clear nasal passages
  • shrinks swollen membranes
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor ifsymptoms persist

Section 53414-9 (53414-9)

If pregnant or breast-feeding,ask a health professional before use.

Purpose

Nasal decongestant

Directions
  • adults and children 6 to under 12 years of age (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 under 6 years of age: ask a doctor

To use pump:

  • to open, hold the actuator to squeeze and turn cap
  • hold with thumb at bottom of bottle and nozzle between fingers
  • before using the first time, prime pump by depressing several times
  • place tip of nozzle just past nasal opening (approximately 1/8")
  • pump 2 or 3 times in each nostril without tilting your head. Sniff deeply.
  • wipe nozzle clean after use
  • to close, turn cap until it 'clicks'
Active Ingredient (Active ingredient)

Oxymetazoline hydrochloride 0.05%

Other Information (Other information)
  • store between 15-29°C (59-84°F)
  • retain carton for future reference on full labeling
Inactive Ingredients (Inactive ingredients)

aloe barbadensis gel, benzalkonium chloride, benzyl alcohol, disodium EDTA, disodium phosphate, dl-alpha tocopherol, eucalyptol, glycerin, hydroxyethylcellulose, menthol, monosodium phosphate, polysorbate 80, purified water

Questions? Comments?

call 877-942-2626 toll free

www.zicam.com

When Using This Product (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 one person may spread infection
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
Principal Display Panel 15 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton)

ZICAM ®

INTENSE

SINUS

RELIEF

OXYMETAZOLINE HCl 0.05%

NASAL DECONGESTANT

12

HOUR

RELIEF

COLDS*ALLERGIES

Maximum Strength

Relief of Sinus

Pressure

No-Drip Liquid ®

NASAL SPRAY

Cooling

Menthol & Eucalyptus

0.50 FL OZ (15 mL)


Advanced Ingredient Data


Raw Label Data

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