Label: SIGNATURE CARE ORIGINAL- oxymetazoline hydrochloride spray
- NDC Code(s): 21130-956-28
- Packager: SAFEWAY, INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 18, 2023
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- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
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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
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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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
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SIGNATURE CARE ORIGINAL
oxymetazoline hydrochloride sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-956 Route of Administration NASAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE 0.05 g in 100 mL Inactive Ingredients Ingredient Name Strength POVIDONE K30 (UNII: U725QWY32X) WATER (UNII: 059QF0KO0R) BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) SODIUM PHOSPHATE DIBASIC DIHYDRATE (UNII: 94255I6E2T) POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A) SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN) BENZYL ALCOHOL (UNII: LKG8494WBH) EDETATE DISODIUM (UNII: 7FLD91C86K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21130-956-28 1 in 1 CARTON 10/18/2023 1 30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 10/18/2023 Labeler - SAFEWAY, INC. (009137209)