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, dl-alpha tocopherol, eucalyptol, glycerin, hydroxyethylcellulose, hydroxylated lecithin, menthol, monosodium phosphate, polysorbate 80, 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: 62750-006-10

ZICAM®

INTENSE
SINUS
RELIEF

NASAL DECONGESTANT
OXYMETAZOLINE HCl

12
HOUR
RELIEF

COLDS*ALLERGIES

Maximum Strength
Relief of Painful
Sinus Pressure

No-Drip Liquid®
NASAL SPRAY

Cooling
Menthol & Eucalyptus

0.50 FL OZ (15 mL)

INGREDIENTS AND APPEARANCE

ZICAM 
oxymetazoline hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62750-006
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)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
eucalyptol (UNII: RV6J6604TK)
glycerin (UNII: PDC6A3C0OX)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)
polysorbate 80 (UNII: 6OZP39ZG8H)
water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62750-006-10	1 in 1 CARTON	05/29/2002
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	05/29/2002

Labeler - Matrixx Initiatives, Inc. (790037253)

Establishment
Name	Address	ID/FEI	Business Operations
Accupac, Inc.		071609663	MANUFACTURE(62750-006)