ZICAM ALLERGY RELIEF- galphimia glauca flowering top, histamine dihydrochloride, luffa operculata fruit, and sulfur gel

Zicam Allergy Relief by

Drug Labeling and Warnings

Zicam Allergy Relief by is a Homeopathic medication manufactured, distributed, or labeled by Matrixx Initiatives, Inc., Unicep. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredients

Galphimia glauca 12x, 30x
Histaminum hydrochloricum 12x, 30x, 200x
Luffa operculata 4x, 12x, 30x
Sulphur 12x, 30x, 200x

Purpose

Upper respiratory allergy symptom relief

Uses

• temporarily relieves symptoms due to hay fever or other upper respiratory allergies such as:
  • sinus pressure
  • itchy, runny nose
  • sneezing
  • itchy, watery eyes
  • nasal congestion

Warnings

For nasal use only.

Ask a doctor before use if you have

• ear, nose, or throat sensitivity
• susceptibility to nosebleeds
• breathing problem such as emphysema or chronic bronchitis

When using this product

• avoid contact with eyes. Rinse right away with water if it gets in eyes and seek medical help right away.
• the use of individual swabs by more than one person may spread infection
• temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may occur

Stop use and ask a doctor if symptoms persist or are accompanied by fever

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 12 years of age and older:
  • open tube (also see illustrations on side of carton):
    • hold tube between thumb and forefinger at the blue band
    • with the other hand hold at base of handle and snap open tube
    • pull out swab
  • apply medication just inside first nostril. Remove swab and press lightly on the outside of first nostril for about 5 seconds. Re-dip swab in tube. Apply medication to second nostril. Remove swab and press lightly on the outside of the second nostril for about 5 seconds. Do not insert swab more than 1/4″ past nasal opening.
  • discard swab after use
  • wait at least 30 seconds before blowing nose
  • use 1 tube every 4 hours
• optimal results may not be seen for 1-2 weeks. After 1-2 weeks, you may need to use only 1-2 times daily. For best results, use up to 1 week before contact with known causes of your allergies.
• children under 12 years of age: ask a doctor

Other information

• store between 15-29°C (59-84°F)

Inactive ingredients

benzalkonium chloride, benzyl alcohol, edetate disodium, glycerin, hydroxyethylcellulose, menthol, potassium chloride, potassium phosphate, purified water, sodium chloride, sodium phosphate

Questions? Comments? Side Effects?

call 877-942-2626 toll free
www.zicam.com

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

PRINCIPAL DISPLAY PANEL - 15 Swab Tube Carton

NDC: 62750-004-15

ZICAM®

GENTLE
ALLERGY
RELIEF

THE ONLY
ALLERGY RELIEF
NASAL SWAB

NASAL SWABS
with Cooling Menthol

Effective Non-Drowsy Relief of:

Nasal Congestion     Itchy Eyes
Itchy, Runny Nose    Sneezing

No Known Allergy Drug Interactions

15 MEDICATED SWABS
HOMEOPATHIC

INGREDIENTS AND APPEARANCE

ZICAM ALLERGY RELIEF 
galphimia glauca flowering top, histamine dihydrochloride, luffa operculata fruit, and sulfur gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62750-004
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GALPHIMIA GLAUCA FLOWERING TOP (UNII: 93PH5Q8M7E) (GALPHIMIA GLAUCA FLOWERING TOP - UNII:93PH5Q8M7E)	GALPHIMIA GLAUCA FLOWERING TOP	30 [hp_X]  in 1.1 mL
HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3)	HISTAMINE DIHYDROCHLORIDE	200 [hp_X]  in 1.1 mL
LUFFA OPERCULATA FRUIT (UNII: C4MO6809HU) (LUFFA OPERCULATA FRUIT - UNII:C4MO6809HU)	LUFFA OPERCULATA FRUIT	30 [hp_X]  in 1.1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	200 [hp_X]  in 1.1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BENZYL ALCOHOL (UNII: LKG8494WBH)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
POTASSIUM PHOSPHATE, UNSPECIFIED FORM (UNII: B7862WZ632)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM PHOSPHATE (UNII: SE337SVY37)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62750-004-15	15 in 1 CARTON	02/15/2015
1		1.1 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED HOMEOPATHIC		02/15/2015

Labeler - Matrixx Initiatives, Inc. (790037253)

Establishment
Name	Address	ID/FEI	Business Operations
Unicep		790263909	MANUFACTURE(62750-004)