Signature Care Original Nasal Spray 1oz 76095

Signature Care Original Nasal Spray 1oz 76095
SPL v4
SPL
SPL Set ID f7ad687b-dcaf-928c-e053-6294a90a6abe
Route
NASAL
Published
Effective Date 2023-10-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oxymetazoline (0.05 g)
Inactive Ingredients
Povidone K30 Water Edetate Disodium Benzalkonium Chloride Sodium Phosphate Dibasic Dihydrate Polyethylene Glycol 1500 Sodium Phosphate, Monobasic, Monohydrate Benzyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-18

Description

Active ingredient Purpose Oxymetazoline hydrochloride 0.05%............ Nasal decongestant


Medication Information

Warnings and Precautions

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
Indications and 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
Dosage and Administration

Distributed by:

Better Living Brands LLC

P.O. Box 99

Pleasanton, CA 94566-0009

Made in China

Description

Active ingredient Purpose Oxymetazoline hydrochloride 0.05%............ Nasal decongestant

Section 44425-7

Other information

  • store at room temperature 20-25° (68-77°F)
Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away

Section 50566-9

Stop use and ask a doctor if symptoms persist

Section 50567-7

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
Section 51727-6

Inactive ingredients

benzalkonium chloride, benzyl alcohol, edetate disodium, polyethylene glycol 1500, povidone k30, purified water, sodium phosphate dibasic, sodium phosphate monobasic monohydrate

Section 51945-4

Section 53414-9

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

Section 55105-1

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
Section 55106-9

Active ingredient Purpose

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


Structured Label Content

Indications and Usage (34067-9)

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
Dosage and Administration (34068-7)

Distributed by:

Better Living Brands LLC

P.O. Box 99

Pleasanton, CA 94566-0009

Made in China

Warnings and Precautions (34071-1)

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
Section 44425-7 (44425-7)

Other information

  • store at room temperature 20-25° (68-77°F)
Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away

Section 50566-9 (50566-9)

Stop use and ask a doctor if symptoms persist

Section 50567-7 (50567-7)

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
Section 51727-6 (51727-6)

Inactive ingredients

benzalkonium chloride, benzyl alcohol, edetate disodium, polyethylene glycol 1500, povidone k30, purified water, sodium phosphate dibasic, sodium phosphate monobasic monohydrate

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

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
Section 55106-9 (55106-9)

Active ingredient Purpose

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


Advanced Ingredient Data


Raw Label Data

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