SIGNATURE CARE ORIGINAL- oxymetazoline hydrochloride spray

Signature Care Original by

Drug Labeling and Warnings

Signature Care Original by is a Otc medication manufactured, distributed, or labeled by SAFEWAY, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient Purpose

Oxymetazoline hydrochloride 0.05%............ Nasal decongestant

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

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

Stop use and ask a doctor if symptoms persist

PREGNANCY OR BREAST FEEDING

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

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

DOSAGE & ADMINISTRATION

Distributed by:

Better Living Brands LLC

P.O. Box 99

Pleasanton, CA 94566-0009

Made in China

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SIGNATURE CARE ORIGINAL 
oxymetazoline hydrochloride spray

Product 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)
EDETATE DISODIUM (UNII: 7FLD91C86K)
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)

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)