Zicam Extreme Congestion Relief Spray
FDA Label NDC 10237-464

12 label sections · Submitted to the FDA by Church & Dwight Co., Inc. · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Church & Dwight Co., Inc. for the product Zicam Extreme Congestion Relief (NDC 10237-464). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, otc - ask doctor, otc - when using, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient

→ Purpose

→ Uses

→ Otc - Ask Doctor

→ Otc - When Using

→ Otc - Stop Use

→ Otc - Pregnancy Or Breast Feeding

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Inactive Ingredients

→ Questions? Comments?

→ Principal Display Panel - 15 Ml Bottle Carton

Active Ingredient

Oxymetazoline hydrochloride 0.05%

Purpose

Nasal decongestant

Uses

temporarily relieves nasal congestion due to:
- the common cold
- hay fever
- upper respiratory allergies
- temporarily relieves sinus congestion and pressure
- helps clear nasal passages
- shrinks swollen membranes

Otc - Ask Doctor

Ask a doctor before use if you have

heart disease
high blood pressure
thyroid disease
diabetes
trouble urinating due to an enlarged prostate gland

Otc - When Using

When using this product

do not use more than directed
do not use for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.
temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge may result
use of this container by more than one person may spread infection

Otc - Stop Use

Stop use and ask a doctor ifsymptoms persist

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

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

Directions

adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
children under 6 years of age: ask a doctor

To use pump:

to open, hold the actuator to squeeze and turn cap
hold with thumb at bottom of bottle and nozzle between fingers
before using the first time, prime pump by depressing several times
place tip of nozzle just past nasal opening (approximately 1/8")
pump 2 or 3 times in each nostril without tilting your head. Sniff deeply.
wipe nozzle clean after use
to close, turn cap until it 'clicks'

Inactive Ingredients

aloe barbadensis gel, benzalkonium chloride, benzyl alcohol, disodium EDTA, disodium phosphate, glycerin, hydroxyethylcellulose, monosodium phosphate, purified water