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NDC 62750-0070-10 Zicam Cold Remedy 4; 4; 4 [hp_X]/.56mL; [hp_X]/.56mL; [hp_X]/.56mL Details

Zicam Cold Remedy 4; 4; 4 [hp_X]/.56mL; [hp_X]/.56mL; [hp_X]/.56mL

Zicam Cold Remedy is a NASAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by Matrixx Initiatives, Inc.. The primary component is GALPHIMIA GLAUCA FLOWERING TOP; LUFFA OPERCULATA FRUIT; SCHOENOCAULON OFFICINALE SEED.

Product Information

NDC	62750-0070
Product ID	62750-070_f4d61fe4-94a2-485f-8b35-ad7416918c77
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Zicam Cold Remedy
Proprietary Name Suffix	n/a
Non-Proprietary Name	galphimia glauca flowering top, luffa operculata fruit, and schoenocaulon officinale seed
Product Type	HUMAN OTC DRUG
Dosage Form	SPRAY
Route	NASAL
Active Ingredient Strength	4; 4; 4
Active Ingredient Units	[hp_X]/.56mL; [hp_X]/.56mL; [hp_X]/.56mL
Substance Name	GALPHIMIA GLAUCA FLOWERING TOP; LUFFA OPERCULATA FRUIT; SCHOENOCAULON OFFICINALE SEED
Labeler Name	Matrixx Initiatives, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	n/a

Package

Package Images

NDC 62750-0070-10 (62750007010)

Pricing Information	N/A
NDC Package Code	62750-070-10
Billing NDC	62750007010
Package	1 BOTTLE, PLASTIC in 1 CARTON (62750-070-10) / 15 mL in 1 BOTTLE, PLASTIC
Marketing Start Date	2014-08-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 6daf52c8-0d91-44d5-b9b4-d03fca16117c Details

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 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? Side Effects?

call 877-942-2626 toll free

SPL UNCLASSIFIED SECTION

Distributed by Matrixx Initiatives, Inc.

Scottsdale, Arizona 85260.

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

NDC 62750-070-10

ZICAM®

COLD REMEDY

SHORTENS COLDS

PLUS MULTI-SYMPTOM RELIEF

GET BETTER

FASTER

TAKE AT THE FIRST

THE

PRE-COLD®

MEDICINE

SIGN OF A COLD

THE

ONLY

CLINICALLY

PROVEN

COLD SHORTENING

NASAL SPRAY

SEE

WHAT'S

INSIDE!

No Drip

NASAL SPRAY

With Cooling Menthol

& Eucalyptus

0.50 FL OZ (15 mL)

ZINC-FREE

HOMEOPATHIC

Principal Display Panel - 15 mL Bottle Carton

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:62750-070
Route of Administration	NASAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:62750-070-10	1 in 1 CARTON	08/01/2014	06/30/2023
1		15 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
UNAPPROVED HOMEOPATHIC		08/01/2014	06/30/2023

Labeler - Matrixx Initiatives, Inc. (790037253)

Name	Address	ID/FEI	Business Operations
Establishment
Accupac, Inc		071609663	MANUFACTURE(62750-070)

Revised: 1/2022

Document Id: f4d61fe4-94a2-485f-8b35-ad7416918c77

Set id: 6daf52c8-0d91-44d5-b9b4-d03fca16117c

Version: 3

Effective Time: 20220131

Search by Drug Name or NDC

NDC 62750-0070-10 Zicam Cold Remedy 4; 4; 4 [hp_X]/.56mL; [hp_X]/.56mL; [hp_X]/.56mL Details

Zicam Cold Remedy 4; 4; 4 [hp_X]/.56mL; [hp_X]/.56mL; [hp_X]/.56mL

Product Information

Package

Package Images

NDC 62750-0070-10 (62750007010)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 6daf52c8-0d91-44d5-b9b4-d03fca16117c Details

SPL UNCLASSIFIED SECTION

Active ingredients

Purpose

Uses

Warnings

Directions

Other information

Inactive ingredients

Questions? Comments? Side Effects?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

INGREDIENTS AND APPEARANCE

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