ZICAM- oxymetazoline hydrochloride spray

Zicam by

Drug Labeling and Warnings

Zicam by is a Otc medication manufactured, distributed, or labeled by Matrixx Initiatives, Inc., Accupac, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient

Oxymetazoline hydrochloride 0.05%

Purpose

Nasal decongestant

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

Warnings

Ask a doctor before use if you have

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an 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 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.

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'

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, glycerin, hydroxyethylcellulose, hydroxylated lecithin, monosodium phosphate, purified water

Questions? Comments? Side Effects?

call 877-942-2626 toll free

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Distributed by Matrixx Initiatives, Inc.
Scottsdale, Arizona 85260.

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

NDC: 62750-005-10

ZICAM®

EXTREME
CONGESTION
RELIEF

NASAL DECONGESTANT
OXYMETAZOLINE HCl

12
HOUR
RELIEF

COLDS*ALLERGIES

Fast, Powerful
Congestion
Relief

No-Drip Liquid®
NASAL SPRAY

Soothing
Aloe Vera

0.50 FL OZ (15 mL)

INGREDIENTS AND APPEARANCE

ZICAM 
oxymetazoline hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62750-005
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
oxymetazoline hydrochloride (UNII: K89MJ0S5VY) (oxymetazoline - UNII:8VLN5B44ZY)	oxymetazoline hydrochloride	.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
aloe vera leaf (UNII: ZY81Z83H0X)
benzalkonium chloride (UNII: F5UM2KM3W7)
benzyl alcohol (UNII: LKG8494WBH)
Edetate Disodium (UNII: 7FLD91C86K)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
glycerin (UNII: PDC6A3C0OX)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)
water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62750-005-10	1 in 1 CARTON	05/20/2002
1		15 mL in 1 BOTTLE, PLASTIC; 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	05/20/2002

Labeler - Matrixx Initiatives, Inc. (790037253)

Establishment
Name	Address	ID/FEI	Business Operations
Accupac, Inc.		071609663	MANUFACTURE(62750-005)