Zicam ®

Zicam ®
SPL v3
SPL
SPL Set ID d91738e5-1d2e-41d1-e053-2995a90a7aad
Route
NASAL
Published
Effective Date 2022-02-28
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 2022-02-28

Description

Drug Facts

Purpose

Reduces duration and severity of the common cold and helps relieve nasal congestion


Medication Information

Purpose

Reduces duration and severity 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 formulated to shorten the duration of the common cold and may not 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 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:
    • 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 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

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
Questions? Comments? Side Effects?

call 877-942-2626 toll free

Ask A Doctor Before Use If You Have
  • ear, nose, or throat sensitivity
  • susceptibility to nosebleeds
Principal Display Panel 20 Swab Tube Carton

ZICAM ®



COLD REMEDY

SHORTENS COLDS

TAKE AT THE FIRST



THE



PRE-COLD ®



MEDICINE




SIGN OF A COLD

THE



ONLY



COLD SHORTENING



NASAL SWAB

Medicated

NASAL SWABS

With Cooling Menthol

& Eucalyptus

20 SINGLE-USE SWABS

ZINC-FREE

HOMEOPATHIC


Structured Label Content

Uses

Reduces duration of the common cold and helps relieve nasal congestion

Zicam ® Cold Remedy was formulated to shorten the duration of the common cold and may not 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 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 and severity 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:
    • 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 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

When Using This Product (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 (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
Questions? Comments? Side Effects?

call 877-942-2626 toll free

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • ear, nose, or throat sensitivity
  • susceptibility to nosebleeds
Principal Display Panel 20 Swab Tube Carton (PRINCIPAL DISPLAY PANEL - 20 Swab Tube Carton)

ZICAM ®



COLD REMEDY

SHORTENS COLDS

TAKE AT THE FIRST



THE



PRE-COLD ®



MEDICINE




SIGN OF A COLD

THE



ONLY



COLD SHORTENING



NASAL SWAB

Medicated

NASAL SWABS

With Cooling Menthol

& Eucalyptus

20 SINGLE-USE SWABS

ZINC-FREE

HOMEOPATHIC


Advanced Ingredient Data


Raw Label Data

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