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

Zicam Cold Remedy by

Drug Labeling and Warnings

Zicam Cold Remedy by is a Homeopathic medication manufactured, distributed, or labeled by Church & Dwight Co., Inc.. 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 of the common cold and helps relieve nasal congestion

Uses

Reduces duration of the common cold and helps relieve nasal congestion

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Zicam ® Cold Remedy was not formulated to 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 this container 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:
  • remove cap and safety clip
  • hold with thumb at bottom of bottle and nozzle between your fingers
  • before using the first time, prime pump by depressing several times
  • place tip of nozzle just past nasal opening (approximately 1/8")
  • lean your head backwards slightly
  • pump 2 times into each nostril
  • avoid inhaling deeply
  • wipe away any excess
  • dose every 3 hours, not to exceed 5 doses in one 24 hour period
• children under 12 years of age: do not 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?

call 877-942-2626 toll free

www.zicam.com

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

ZICAM ®

COLD REMEDY

SHORTENS COLDS

TAKE AT THE FIRST

THE
PRE-COLD ®
MEDICINE

SIGN OF A COLD

THE

ONLY

COLD SHORTENING

NASAL SPRAY

No Drip
NASAL SPRAY

With Cooling Menthol
& Eucalyptus

0.50 FL OZ (15 mL)

ZINC-FREE
HOMEOPATHIC

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10237-474
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 0.56 mL
LUFFA OPERCULATA FRUIT (UNII: C4MO6809HU) (LUFFA OPERCULATA FRUIT - UNII:C4MO6809HU)	LUFFA OPERCULATA FRUIT	4 [hp_X]  in 0.56 mL
SCHOENOCAULON OFFICINALE SEED (UNII: 6NAF1689IO) (SCHOENOCAULON OFFICINALE SEED - UNII:6NAF1689IO)	SCHOENOCAULON OFFICINALE SEED	4 [hp_X]  in 0.56 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: 10237-474-15	1 in 1 CARTON	04/10/2022
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
unapproved homeopathic		04/10/2022

Labeler - Church & Dwight Co., Inc. (001211952)