CoFix RX

Manufacturer
LXR Biotech LLC
Effective date
2022-12-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:44:07

Label at a glance#

ProductCoFix RX
Active ingredientPOVIDONE-IODINE
Label structure12 sections

Dosage and administration

■ Adults and children over 6 years of age: 1 spray in each nostril not more than 3 times in any 24-hour period ■ Children under 6 years of age: consult a doctor ■ To use shake well, remove cap, spray directly up nostril quickly and firmly. Do not tilt head backward while spraying. Wipe spray nozzle clean and secure cap following use. Do not share applicators.

Storage and handling

Protect from freezing and excessive heat store at room temperature may stain clothing avoid contact with the jewelry Keep the carton for complete warning and information

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Povidone-Iodine 1.25 % Purpose: Antiviral

Purpose

OTC - PURPOSE SECTION

Antiviral

Use

INDICATIONS & USAGE SECTION

Antiviral to temporarily prevent viral infection and transmission

Warnings

WARNINGS SECTION

Ask a doctor before use if you have
■ had nose ulcers or nose surgery ■ had a nose injury that has not healed ■ trouble urinating due to an enlarged prostate ■ heart disease ■ thyroid disease ■ high blood pressure ■ diabetes ■ shellfish allergy

Do not use

OTC - DO NOT USE SECTION

■ if allergic to iodine or inactive ingredient(s) ■ in the eyes ■ on children less than 3 years old

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding ask a healthcare professional before use.

OTC - STOP USE SECTION

Stop use and ask a doctor if symptoms persist or worsen ■ swelling, infection, rash, or fever occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

■ Adults and children over 6 years of age: 1 spray in each nostril not more than 3 times in any 24-hour period

■ Children under 6 years of age: consult a doctor

■ To use shake well, remove cap, spray directly up nostril quickly and firmly. Do not tilt head backward while spraying. Wipe spray nozzle clean and secure cap following use. Do not share applicators.

Other information

STORAGE AND HANDLING SECTION

Protect from freezing and excessive heat

store at room temperature

may stain clothing

avoid contact with the jewelry

Keep the carton for complete warning and information

Inactive ingredients

INACTIVE INGREDIENT SECTION

carrageenan, gellan gum, polysorbate, purified water, sodium hydroxide, vitamin D3, xylitol

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

10 mL NDC:78299-211-1110 mL NDC:78299-211-1110 mL NDC:78299-221-11

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78299-22178299-221-11

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
fbf37d8c-7836-8baf-e053-6394a90a47eec1226d9a-a52a-79c2-e053-2995a90af0182023-05-18WarningsExact identifier
spl set id: c1226d9a-a52a-79c2-e053-2995a90af018

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.