SEPTICARE- benzethonium chloride solution 
Sage Pharmaceuticals, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Septicare™

Drug Facts

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.

Warnings

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.

For external use only.

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.

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

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

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
SEPTICARE 
benzethonium chloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59243-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X) 9 mg  in 1 mL
POLOXAMER 188 (UNII: LQA7B6G8JG)  
POLIHEXANIDE (UNII: 322U039GMF)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59243-100-08240 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart333A06/26/1999
Labeler - Sage Pharmaceuticals, Inc. (626120919)

Revised: 8/2013
Document Id: e3cd2717-4e68-4fa1-9ca9-4d0aee15a933
Set id: cd731ea7-75bf-4369-ba68-127f07af3e42
Version: 1
Effective Time: 20130805
 
Sage Pharmaceuticals, Inc.