Nasal
FDA Label NDC 70005-038

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by We Care Distributor Inc. for the product Nasal (NDC 70005-038). 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 other, active ingredient, purpose, uses, otc - ask doctor, otc - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient

Oxymetazoline Hydrochloride 0.05%

Purpose

Nasal Decongestant

Uses

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

Otc - Ask Doctor

Ask a doctor before use if you have

  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to 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 one person may spread infection

Otc - Stop Use

Stop use and ask 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.

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 within 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

  • store between 20° to 25° C (68° to 77° F)
  • retain carton for future reference on full labeling.

Inactive Ingredients

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

Questions Or Comments?

1-888-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com

Principal Display Panel - 15 Ml Carton

WE CARE

12 Hour NASAL SPRAY
DECONGESTANT

oxymetazoline hydrochloride 0.05%

Compare to active ingredient of Afrin

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