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NDC 62750-0060-10 Zicam Cold Remedy Oral Mist 2; 1 [hp_X]/mL; [hp_X]/mL Details

Zicam Cold Remedy Oral Mist 2; 1 [hp_X]/mL; [hp_X]/mL

Zicam Cold Remedy Oral Mist is a ORAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by Matrixx Initiatives, Inc.. The primary component is ZINC ACETATE; ZINC GLUCONATE.

Product Information

NDC	62750-0060
Product ID	62750-060_178b8a6e-2e35-4bce-b90f-c63104b0f419
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 Oral Mist
Proprietary Name Suffix	n/a
Non-Proprietary Name	ZINC ACETATE and ZINC GLUCONATE
Product Type	HUMAN OTC DRUG
Dosage Form	SPRAY
Route	ORAL
Active Ingredient Strength	2; 1
Active Ingredient Units	[hp_X]/mL; [hp_X]/mL
Substance Name	ZINC ACETATE; ZINC GLUCONATE
Labeler Name	Matrixx Initiatives, Inc.
Pharmaceutical Class	Copper Absorption Inhibitor [EPC], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Decreased Copper Ion Absorption [PE]
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	n/a

Package

Package Images

NDC 62750-0060-10 (62750006010)

Pricing Information	N/A
NDC Package Code	62750-060-10
Billing NDC	62750006010
Package	1 BOTTLE, PLASTIC in 1 CARTON (62750-060-10) / 30 mL in 1 BOTTLE, PLASTIC
Marketing Start Date	2013-03-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ea926827-cfea-4a5d-842e-057165de2216 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Zincum aceticum 2x

Zincum gluconicum 1x

Purpose

Reduces duration and severity of the common cold

Uses

reduces duration of the common cold
helps reduce severity of cold symptoms:
- sore throat
- stuffy nose
- sneezing
- coughing
- nasal congestion

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

Warnings

For oral use only

Sore throat warning

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Ask a doctor before use if you have a sensitivity to zinc or are allergic to zinc

When using this product avoid contact with eyes. Rinse right away with water if it gets in eyes and seek medical help right away.

Stop use and ask a doctor if symptoms, including cough, persist, recur or are accompanied by a fever, rash, or persistent headache, or if new symptoms occur. A persistent cough that lasts for more than one week may be a sign of a serious condition.

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

Keep out of reach of children. In case of overdose, 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:
- spray 4 times in mouth at the onset of symptoms. Spray on inside of cheeks, roof of mouth and gums. Retain for 15 seconds. Swallow.
- repeat every 2- 3 hours, not to exceed 7 doses in 24 hours. Take until symptoms are gone.
- to avoid minor stomach upset, do not take on an empty stomach
- do not eat or drink for 15 minutes after use. Do not eat or drink citrus fruits or juices for 30 minutes before or after use. Otherwise, drink plenty of fluids.
children under 12 years of age: ask a doctor before use

Other information

store between 15-29°C (59-84°F)

Inactive ingredients

benzalkonium chloride, glycerin, menthol, natural & artificial flavor, PEG-40 hydrogenated castor oil, purified water, sucralose, xylitol

Questions? Comments? Side Effects?

call 877-942-2626 toll free

SPL UNCLASSIFIED SECTION

Distributed by Matrixx Initiatives, Inc.

Scottsdale, Arizona 85260.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

NDC 62750-060-10

ZICAM®

COLD REMEDY

SHORTENS COLDS

+ SOOTHES SORE THROATS

AND COUGHS

TAKE AT THE FIRST

SIGN OF A COLD

THE

PRE-COLD®

MEDICINE

SEE

WHAT'S

INSIDE!

CLINICALLY PROVEN TO SHORTEN COLDS

ORAL MIST™

GREAT TASTING

Arctic Mint Flavor

1.0 FL OZ

(30 mL)

HOMEOPATHIC

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

INGREDIENTS AND APPEARANCE

ZICAM COLD REMEDY ORAL MIST

zinc acetate and zinc gluconate spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62750-060
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	2 [hp_X] in 1 mL
ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC GLUCONATE	1 [hp_X] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
WATER (UNII: 059QF0KO0R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XYLITOL (UNII: VCQ006KQ1E)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:62750-060-10	1 in 1 CARTON	03/01/2013	09/30/2023
1		30 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		03/01/2013	09/30/2023

Labeler - Matrixx Initiatives, Inc. (790037253)

Name	Address	ID/FEI	Business Operations
Establishment
Accupac, Inc		071609663	MANUFACTURE(62750-060)

Revised: 1/2022

Document Id: 178b8a6e-2e35-4bce-b90f-c63104b0f419

Set id: ea926827-cfea-4a5d-842e-057165de2216

Version: 4

Effective Time: 20220131

Search by Drug Name or NDC

NDC 62750-0060-10 Zicam Cold Remedy Oral Mist 2; 1 [hp_X]/mL; [hp_X]/mL Details

Zicam Cold Remedy Oral Mist 2; 1 [hp_X]/mL; [hp_X]/mL

Product Information

Package

Package Images

NDC 62750-0060-10 (62750006010)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL ea926827-cfea-4a5d-842e-057165de2216 Details

SPL UNCLASSIFIED SECTION

Active ingredients

Purpose

Uses

Warnings

Sore throat warning

Directions

Other information

Inactive ingredients

Questions? Comments? Side Effects?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

INGREDIENTS AND APPEARANCE

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