Shopko Extra Moisturizing Nasal
FDA Label NDC 65923-977

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by United Exchange Corp. for the product Shopko Extra Moisturizing Nasal (NDC 65923-977). 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 - ask doctor, otc - when using, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredient                                                                Purpose

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

Otc - Purpose

Uses

  • temporarily relieves nasal decongestant due to:
  • common cold
  • hay fever
  • upper respiratory allergies
  • sinusitis
  • shrinks swollen nasal membranes so you can breathe more freely

Warnings

Warnings

For external use only

Otc - Ask Doctor

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 on 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 right away.

Indications & Usage

Directions

  • adults and children 6 to 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: ask a doctor
    • To spray, squeeze bottle quickly and firmly.  Do not tilt head backward while spraying.  Wipe nozzle clean after use.

Storage And Handling

Other information

  • store between 2o and 30oC (36o and 86oF)
  • retain carton for future reference on full labeling

Inactive Ingredient

Inactive ingredients

benzalkonium chloride solution, edetate disodium, glycerin, polyethylene glycol, povidone, propylene glycol, sodium phosphate dibasic, sodium phosphate monobasic, water

Dosage & Administration

Distributed by:

UNITED EXCHANGE CORP.

17211 Valley View Ave.

Cerritos, CA 90703 USA

Made in Korea

Package Label.Principal Display Panel

Image Of Carton Label (Shopkonasalsprayexmoist)

Image Of Carton Label (Shopkonasalsprayexmoist)

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