Zicam ®

Zicam ®
SPL v2
SPL
SPL Set ID dc29d796-5853-6992-e053-2995a90ab6bd
Route
NASAL
Published
Effective Date 2022-04-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Galphimia Glauca Flowering Top (4 [hp_X]) Luffa Operculata Fruit Schoenocaulon Officinale Seed
Inactive Ingredients
Benzalkonium Chloride Sodium Phosphate, Dibasic, Unspecified Form Eucalyptol Eugenol Glycine Hypromellose, Unspecified Menthol, Unspecified Form Sodium Phosphate, Monobasic, Unspecified Form Phenylethyl Alcohol Polysorbate 80 Water Saccharin Sodium Sodium Chloride Succinic Acid

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2022-04-10

Description

Drug Facts

Purpose

Reduces duration of the common cold and helps relieve nasal congestion


Medication Information

Purpose

Reduces duration of the common cold and helps relieve nasal congestion

Description

Drug Facts

Uses

Reduces duration of the common cold and helps relieve nasal congestion

---------------------------------------------------------------------------------------------------

Zicam ® Cold Remedy was not formulated to be effective for flu or allergies.

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

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
Section 50567-7

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
Section 50569-3

Ask a doctor before use if you have

  • ear, nose, or throat sensitivity
  • susceptibility to nosebleeds
Section 50570-1

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.

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Warnings
  • For nasal use only
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)
Active Ingredients

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

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


Structured Label Content

Uses

Reduces duration of the common cold and helps relieve nasal congestion

---------------------------------------------------------------------------------------------------

Zicam ® Cold Remedy was not formulated to be effective for flu or allergies.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

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
Section 50567-7 (50567-7)

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
Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • ear, nose, or throat sensitivity
  • susceptibility to nosebleeds
Section 50570-1 (50570-1)

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.

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Reduces duration of the common cold and helps relieve nasal congestion

Warnings
  • For nasal use only
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 (Other information)
  • store at room temperature 15-29°C (59-84°F)
Active Ingredients (Active ingredients)

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

Inactive Ingredients (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 (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


Advanced Ingredient Data


Raw Label Data

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