Otc - Active Ingredient
Active ingredient Purpose
Oxymetazoline hydrochloride 0.05%............ Nasal decongestant
Signature Care Original Spray
FDA Label NDC 21130-956
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Safeway, Inc. for the product Signature Care Original (NDC 21130-956). 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 otc - active ingredient, otc - purpose, warnings, otc - when using, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses
- temporarily relieves nasal congestion due to:
- common cold
- hay fever
- upper respiratory allergies
- temporarily relieves sinus congestion and pressure
- shrinks swollen nasal membranes so you can breathe more freely
Warnings
Warnings
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 occur
- use of this container by more than one person may spread infection
Otc - Stop Use
Stop use and ask a doctor if symptoms 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 (1-800-222-1222) right away
Indications & Usage
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: consult a doctor
- shake well before use. Remove safety seal. To open, rotate cap to align the marks. Squeeze cap on both sides in a counter-clockwise turn and pull off to remove. To spray, remove clamp and hold bottle with thumb at base and nozzle between first and second fingers. Without tilting the head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use and snap cap onto bottle
Storage And Handling
Other information
- store at room temperature 20-25° (68-77°F)
Inactive Ingredient
Inactive ingredients
benzalkonium chloride, benzyl alcohol, edetate disodium, polyethylene glycol 1500, povidone k30, purified water, sodium phosphate dibasic, sodium phosphate monobasic monohydrate
Dosage & Administration
Distributed by:
Better Living Brands LLC
P.O. Box 99
Pleasanton, CA 94566-0009
Made in China
Package Label.Principal Display Panel
76095 (76095)
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