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First Aid Direct Cold-EEZE Cold Remedy

First Aid Direct Cold-EEZE Cold Remedy

Approved
Approval ID

a6c5906d-8f04-42f7-885f-e7490ec6b5bc

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 23, 2025

Manufacturers
FDA

Cintas Corporation

DUNS: 056481716

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Zinc Gluconate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code42961-105
Product Classification
G
Generic Name
Zinc Gluconate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 23, 2025
FDA Product Classification

INGREDIENTS (5)

ZINC GLUCONATEActive
Quantity: 2 [hp_X] in 1 1
Code: U6WSN5SQ1Z
Classification: ACTIB
CORN SYRUPInactive
Code: 9G5L16BK6N
Classification: IACT
GLYCINEInactive
Code: TE7660XO1C
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
CHERRYInactive
Code: BUC5I9595W
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/23/2025

Principal Display Panel

Cold-EEZE®

Cold Remedy Lozenge

Zinc Gluconate Homeeopathic

NATURAL CHERRY FLAVOR

Formulated to reduce the duration of the common cold when taken at the first sign of symptoms.

20 Lozenges per box

PDP

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 7/20/2023

Uses

  • reduces the duration of the common cold
  • reduces the severity of cold symptoms: cough, sore throat, nasal congestion, post nasal drip and/or hoarseness

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/23/2025

Active ingredient (per lozenge)

Zinc Gluconate 2X HPUS† (2.3%) (13.3 mg zinc)

†The letters 'HPUS' indicate that the active ingredient is in the official Homeopathic Pharmacopeia of the United States.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 7/20/2023

Purpose

Cold remedy

WARNINGS SECTION

LOINC: 34071-1Updated: 7/20/2023

Warnings

Do not use for treatment of influenza or allergies. This product is intended only to reduce the duration of the common cold and its symptoms

Ask a doctor or pharmacist before use if you are taking minocycline, doxycycline, tetracycline or are on Coumadin (warfarin) therapy. Zinc treatment may inhibit the absorption of these medicines.

When using this product do not take on an empty stomach (to avoid possible minor stomach upset)

Stop use and ask your doctor if symptoms persist more than 7 days

If pregnant or breastfeeding, ask a healthcare professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 7/20/2023

Directions

  • take one lozenge at the onset of symptoms
  • dissolve entire lozenge in mouth
  • do not chew
  • do not swallow whole
  • do not eat or drink for 15 minutes after use
  • repeat every 2-4 hours until symptoms subside
  • Adults 18 years and over: do not exceed 6 lozenges per day
  • Children 12 to under 18 years: do not exceed 4 lozenges per day
  • Children under 12 years: ask a doctor before use

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 7/20/2023

Other information

  • store in a cool, dry place after opening
  • best if used within 6 months after opening

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 7/20/2023

Inactive ingredients

corn syrup, glycine, natural flavors, sucrose

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 7/20/2023

Questions?

1-800-327-2704 m-F 8am-5pm EST

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First Aid Direct Cold-EEZE Cold Remedy - FDA Drug Approval Details