Septicare
FDA Label NDC 59243-100

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sage Pharmaceuticals, Inc. for the product Septicare (NDC 59243-100). 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, when using this product, stop using this product, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Other

Drug Facts

For external use only.

Protocol: Shake before use. Cleaning: Spray on the affected peritoneal area and remove with a moist washcloth. Aides in the removal of urine feces and other foreign material.

Manufactured by:
SAGE
PHARMACEUTICALS
5408 Interstate Drive
Shreveport, LA 71109

Active Ingredient

Benzethonium Chloride 0.2%

Purpose

Antiseptic

Uses

For skin irritation due to incontinence. Protects against the risk of bacterial contamination in minor cuts, scrapes, and burns.

When Using This Product

Do not use in the eyes, with deep or puncture wounds, serious burns or animal bites.

Stop Using This Product

If skin irritation and redness develop.

  • If condition persists for more than 72 hours, consult a physician.

Otc - Keep Out Of Reach Of Children

Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adjust nozzle to spray or stream setting. Spray/stream Septicare directly into wound, or soak gauze pad and pack the wound. Cover with secondary dressing of choice. Change dressing as needed, no rinsing necessary.

Inactive Ingredients

water, sodium chloride 0.9%, nonionic surfactant, biguanide.

Storage And Handling

Store at controlled room temperature between 50°F (10°C) and 86°F (30°C).

Principal Display Panel - 240 Ml Bottle Label

NDC 59243-100-08

SeptiCare

Wound Cleanser and Deodorant

Antiseptic

Saline based • No-rinse • Non-toxic • Non-stinging

Net Contents: 8 fl.oz. (240 mL)

Principal Display Panel (240 mL Bottle Label)

Principal Display Panel (240 mL Bottle Label)

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