ZICAM COLD REMEDY- galphimia glauca flowering top, luffa operculata fruit, and schoenocaulon officinale seed gel

Zicam Cold Remedy by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Galphimia glauca 4x, Luffa operculata 4x, Sabadilla 4x

Purpose

Reduces duration and severity of the common cold

Uses

• reduces duration of the common cold
• reduces severity of cold symptoms:
  • dry, scratchy throat
  • runny nose
  • watery eyes
  • sneezing
  • nasal congestion

Zicam® Cold Remedy was formulated to shorten the duration of the common cold and may not be effective for flu or allergies.

Warnings

• For nasal use only

Do not use if you have a sensitivity or allergy to any of the ingredients. If an allergic reaction occurs, stop use and seek medical help right away.

Ask a doctor before use if you have

• ear, nose, or throat sensitivity
• susceptibility to nosebleeds

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 get worse or last more than 7 days or are accompanied by fever
• redness or swelling is present
• new symptoms occur

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

• for best results, use at the first sign of a cold and continue to use until symptoms completely subside
• adults and children 12 years of age and older:
  • open tube (also see illustration on side of carton)
  • hold tube between thumb and forefinger at the blue band
  • with other hand, hold at handle base, snap open tube and pull out swab
  • apply medication just inside first nostril. Using swirling motion, rotate swab 3 times within nostril. While swirling, gently press outside of first nostril to ensure transfer of medication. Re-dip swab in tube and mix to re-saturate with medication. Swirl 3 more times in the same nostril while gently pressing outside of nostril. Re-dip swab in tube and mix. Repeat identical sequence in second nostril. 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 3 hours, not to exceed 5 tubes in one 24 hour period
• children under 12 years of age: do no use

Other information

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

Inactive ingredients

benzalkonium chloride, dibasic sodium phosphate, eucalyptol, eugenol, glycine, hypromellose, menthol, monobasic sodium phosphate, phenethyl alcohol, polysorbate 80, purified water, saccharin sodium, sodium chloride, succinic acid

Questions? Comments? Side Effects?

call 877-942-2626 toll free

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 20 Swab Tube Carton

NDC: 62750-073-10

ZICAM®
COLD REMEDY

SHORTENS COLDS

PLUS MULTI-SYMPTOM RELIEF

TAKE AT THE FIRST
THE
PRE-COLD®
MEDICINE
SIGN OF A COLD

THE
ONLY
CLINICALLY PROVEN
COLD SHORTENING
NASAL SWAB

NASAL SWABS

With Cooling Menthol
& Eucalyptus

20 MEDICATED SWABS

ZINC-FREE
HOMEOPATHIC

INGREDIENTS AND APPEARANCE

ZICAM COLD REMEDY 
galphimia glauca flowering top, luffa operculata fruit, and schoenocaulon officinale seed gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62750-073
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	4 [hp_X]  in 1.2 mL
LUFFA OPERCULATA FRUIT (UNII: C4MO6809HU) (LUFFA OPERCULATA FRUIT - UNII:C4MO6809HU)	LUFFA OPERCULATA FRUIT	4 [hp_X]  in 1.2 mL
SCHOENOCAULON OFFICINALE SEED (UNII: 6NAF1689IO) (SCHOENOCAULON OFFICINALE SEED - UNII:6NAF1689IO)	SCHOENOCAULON OFFICINALE SEED	4 [hp_X]  in 1.2 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)
EUCALYPTOL (UNII: RV6J6604TK)
EUGENOL (UNII: 3T8H1794QW)
GLYCINE (UNII: TE7660XO1C)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SUCCINIC ACID (UNII: AB6MNQ6J6L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62750-073-10	20 in 1 CARTON	02/28/2015
1		1.2 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		02/28/2015

Labeler - Matrixx Initiatives, Inc. (790037253)

Establishment
Name	Address	ID/FEI	Business Operations
Unicep		790263909	MANUFACTURE(62750-073)