FDA Label for Oxymetazoline Hcl
View Indications, Usage & Precautions
Oxymetazoline Hcl Product Label
The following document was submitted to the FDA by the labeler of this product Purinepharma Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active Ingredient: Oxymetazoline HCl 0.05%
Otc - Purpose
Purpose: Nasal Decongestant
Indications & Usage
Uses
Temporarily relieves nasal congestion due to:
- common cold
- hay fever
- upper respiratory allergies
- sinusitis
- shrinks swollen nasal membrances so you can breathe more freely.
Otc - Ask Doctor
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
Otc - Do Not Use
When using this product: do not use more than directed
Do not use for more than 3 days. Use only as directed.
Otc - When Using
When using this product
- Frequent or prolonged use may cause nasal congestion to rcur or worsen
- temporary discomfort such as buming, stinging, sneezing or an increase in nasal discharge may occur
- use of this container by more than one person may spread infection
Otc - Pregnancy Or Breast Feeding
Otc - Keep Out Of Reach Of Children
Dosage & Administration
Children under six years of age: ask a doctor.
To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use.
Storage And Handling
Store between 20°C to 25°C (68° to 77° F)
Retain carton for future reference on full labeling.
Inactive Ingredient
Purified Water, Edetate Disodium, Sodium Phosphate Dibasic, Sodium Phosphate Monobasic, Povidone, Benzalkonium Chloride Solution, Polyethylene Glycol, Propylene Glycol
How Supplied
NDC 58599-027-01: 30 mL in a Bottle, NDC 58599-027-17: 15 mL in a Bottle
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