Label: AQUA MARIS FAST ACTING DECONGESTANT- xylometazoline hcl spray
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated December 1, 2012
If you are a consumer or patient please visit this version.
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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 occur
- Wipe nozzle after each use. The use of this dispenser by more than one person may spread infection
- STOP USE
- Adults and children 12 years of age or over: 2 or 3 sprays into each nostril not more often than every 8 to 10 hours
- Do not use more than 3 doses in 24 hours
- Do not give to children under 12 years of age unless directed by a doctor.
To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostril. Fully depress pump all the way down with a firm even stroke and sniff deeply. Wipe nozzle clean after use.
- DOSAGE & ADMINISTRATION
- Other information
- Inactive Ingredients
- Question or comments?
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
AQUA MARIS FAST ACTING DECONGESTANT
xylometazoline hcl spray
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76260-106 Route of Administration NASAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength XYLOMETAZOLINE HYDROCHLORIDE (UNII: X5S84033NZ) (XYLOMETAZOLINE - UNII:WPY40FTH8K) XYLOMETAZOLINE HYDROCHLORIDE 10 mg in 10 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76260-106-30 1 in 1 CARTON 1 10 mL in 1 BOTTLE, SPRAY Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 12/15/2012 Labeler - JGL North America LLC (968070503)