SPL v4
SPL
SPL Set ID 1c1db71a-47d0-42ac-8cbe-95e76dca185f
Route
NASAL
Published
Effective Date 2019-03-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oxymetazoline (0.0005 g)
Inactive Ingredients
Water Citrus Paradisi (grapefruit) Seed Oil Xylitol Benzalkonium Chloride

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-03-12

Description

The use of this container by more than one person may spread infection. Keep out of reach of children. Clean nozzle after each use & replace the cap. Do not exceed recommended dosage. Do not use this product for more than 3 days. If pregnant or breast-feeding, ask a health professional before use. Ask a physician before use if you have - heart disease - high blood pressure - thyroid disease - diabetes - trouble urinating due to enlarged prostate gland - Not for children under age 6 unless directed by a physician.

Purpose

Uses: For temporary relief of nasal decongestion due to colds, hay fever or upper respiratory allergies, or associated with sinusitis. Helps soothe & moisturize nasal passages. Thins & loosens mucous secretions.


Medication Information

Warnings and Precautions

The use of this container by more than one person may spread infection. Keep out of reach of children. Clean nozzle after each use & replace the cap. Do not exceed recommended dosage. Do not use this product for more than 3 days. If pregnant or breast-feeding, ask a health professional before use. Ask a physician before use if you have - heart disease - high blood pressure - thyroid disease - diabetes - trouble urinating due to enlarged prostate gland - Not for children under age 6 unless directed by a physician.

Purpose

Uses: For temporary relief of nasal decongestion due to colds, hay fever or upper respiratory allergies, or associated with sinusitis. Helps soothe & moisturize nasal passages. Thins & loosens mucous secretions.

Description

The use of this container by more than one person may spread infection. Keep out of reach of children. Clean nozzle after each use & replace the cap. Do not exceed recommended dosage. Do not use this product for more than 3 days. If pregnant or breast-feeding, ask a health professional before use. Ask a physician before use if you have - heart disease - high blood pressure - thyroid disease - diabetes - trouble urinating due to enlarged prostate gland - Not for children under age 6 unless directed by a physician.

Uses

Uses: For temporary relief of nasal decongestion due to colds, hay fever or upper respiratory allergies, or associated with sinusitis. Helps soothe & moisturize nasal passages. Thins & loosens mucous secretions.

Warnings

The use of this container by more than one person may spread infection. Keep out of reach of children. Clean nozzle after each use & replace the cap. Do not exceed recommended dosage. Do not use this product for more than 3 days. If pregnant or breast-feeding, ask a health professional before use. Ask a physician before use if you have - heart disease - high blood pressure - thyroid disease - diabetes - trouble urinating due to enlarged prostate gland - Not for children under age 6 unless directed by a physician.

Inactives

Inactive ingredients: Benzalkonium Chloride, Grapefruit Seed Extract, Purified Water, Xylitol

Directions

Directions: Shake well before using. The metered pump sprayer provides a precise amount of soothing spray in a fine mist. Clear the nasal passage-way by gently blowing your nose before using. Prior to initial use, remove cap, prime the pump by holding it upright and pumping one or more times until the solution is dispensed. Insert nozzle into nostril and depress pump completly while breathing in through nose. Clean nozzle after use. Ages 6 years to adult (with adult supervision) - spray 1-2 times in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.

Directions

Directions: Shake well before using. The metered pump sprayer provides a precise amount of soothing spray in a fine mist. Clear the nasal passage-way by gently blowing your nose before using. Prior to initial use, remove cap, prime the pump by holding it upright and pumping one or more times until the solution is dispensed. Insert nozzle into nostril and depress pump completely while breathing in through nose. Clean nozzle after use. Ages 6 years to adult (with adult supervision) - spray 1-2 times in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.

Otc Purpose

Uses: For temporary relief of nasal decongestion due to colds, hay fever or upper respiratory allergies, or associated with sinusitis. Helps soothe & moisturize nasal passages. Thins & loosens mucous secretions.

Active Section

Active ingredients: Oxymetazoline HCL 0.05% ................. Nasal Decongestant

Image of Display Carton


Structured Label Content

Uses

Uses: For temporary relief of nasal decongestion due to colds, hay fever or upper respiratory allergies, or associated with sinusitis. Helps soothe & moisturize nasal passages. Thins & loosens mucous secretions.

Warnings and Precautions (34071-1)

The use of this container by more than one person may spread infection. Keep out of reach of children. Clean nozzle after each use & replace the cap. Do not exceed recommended dosage. Do not use this product for more than 3 days. If pregnant or breast-feeding, ask a health professional before use. Ask a physician before use if you have - heart disease - high blood pressure - thyroid disease - diabetes - trouble urinating due to enlarged prostate gland - Not for children under age 6 unless directed by a physician.

Warnings

The use of this container by more than one person may spread infection. Keep out of reach of children. Clean nozzle after each use & replace the cap. Do not exceed recommended dosage. Do not use this product for more than 3 days. If pregnant or breast-feeding, ask a health professional before use. Ask a physician before use if you have - heart disease - high blood pressure - thyroid disease - diabetes - trouble urinating due to enlarged prostate gland - Not for children under age 6 unless directed by a physician.

Inactives (inactives)

Inactive ingredients: Benzalkonium Chloride, Grapefruit Seed Extract, Purified Water, Xylitol

Directions

Directions: Shake well before using. The metered pump sprayer provides a precise amount of soothing spray in a fine mist. Clear the nasal passage-way by gently blowing your nose before using. Prior to initial use, remove cap, prime the pump by holding it upright and pumping one or more times until the solution is dispensed. Insert nozzle into nostril and depress pump completly while breathing in through nose. Clean nozzle after use. Ages 6 years to adult (with adult supervision) - spray 1-2 times in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.

Directions (directions)

Directions: Shake well before using. The metered pump sprayer provides a precise amount of soothing spray in a fine mist. Clear the nasal passage-way by gently blowing your nose before using. Prior to initial use, remove cap, prime the pump by holding it upright and pumping one or more times until the solution is dispensed. Insert nozzle into nostril and depress pump completely while breathing in through nose. Clean nozzle after use. Ages 6 years to adult (with adult supervision) - spray 1-2 times in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.

Otc Purpose (OTC Purpose)

Uses: For temporary relief of nasal decongestion due to colds, hay fever or upper respiratory allergies, or associated with sinusitis. Helps soothe & moisturize nasal passages. Thins & loosens mucous secretions.

Active Section (active section)

Active ingredients: Oxymetazoline HCL 0.05% ................. Nasal Decongestant

Image of Display Carton (image of display carton)


Advanced Ingredient Data


Raw Label Data

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