PS2 Aciurgy Pack (Page 3 of 3)

Other information

  • store at 20-25º C (68-77ºF)
  • avoid excessive heat above 40ºC (104ºF)

Inactive ingredients

cocamide DEA, fragrance, glucono-delta-lactone, hydroxethylcellulose, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol

​——————– 940-941 Povidone-Iodine Prep Pads ——————–

Drug Facts

Active ingredient

Povidone-Iodine, 10% w/w

Purpose

Antiseptic

Uses

  • First aid antiseptic to help prevent infection in minor cuts, scrapes and burns

Warnings

For external use only.

Do not use

  • in the eyes
  • longer than 1 week unless directed by a physician
  • on individuals who are allergic or sensitive to iodine
  • or apply over large areas of the body

Stop use and ask a doctor if

  • irritation and redness develop
  • condition persists for more than 72 hours
  • in case of deep or puncture wounds, animal bites or serious burns

Keep out of reach of children.

If swallowed, get medical assistance or immediately contact a Poison Control Center.

Directions

  • clean the affected area
  • apply a small amount of this product on the area 1 to 3 times daily.
  • may be covered with a sterile bandage
  • if bandaged, let dry first

Other information

  • do not flush
  • protect from freezing, avoid excessive heat

Inactive ingredients

citric acid, disodium phosphate, water

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Mupirocin Ointment USP, 2%

Rx Only

NET WT 22 g

Mupirocin Ointment USP, 2%
(click image for full-size original)

Chlorhexidine Gluconate 4%

Chlorhexidine Gluconate 4%
(click image for full-size original)

Povidone-Iodine, USP 10%

Povidone-Iodine, USP 10%
(click image for full-size original)

PS2 Aciurgy Pack

Mupirocin 2%

Chlorhexidine Gluconate 4%

Povidone-Iodine, USP 10%

NDC 69263-966-01

Oaklock LLC

carton
(click image for full-size original)
PS2 ACIURGY PACK
mupirocin 2%, chlorhexidine gluconate 4%, povidone-iodine kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69263-966
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69263-966-01 1 KIT in 1 KIT None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 TUBE 22 g
Part 2 1 BOTTLE, PLASTIC 118 mL
Part 3 1 PACKET 1 mL
Part 1 of 3
MUPIROCIN
mupirocin ointment
Product Information
Item Code (Source) NDC:45802-112
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MUPIROCIN (MUPIROCIN) MUPIROCIN 20 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL, UNSPECIFIED
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45802-112-22 1 TUBE in 1 CARTON contains a TUBE
1 22 g in 1 TUBE This package is contained within the CARTON (45802-112-22)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065123
Part 2 of 3
ANTISEPTIC SKIN CLEANSER
chlorhexidine gluconate solution
Product Information
Item Code (Source) NDC:0116-1061
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORHEXIDINE GLUCONATE (CHLORHEXIDINE) CHLORHEXIDINE GLUCONATE 4 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
COCO DIETHANOLAMIDE
GLUCONOLACTONE
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)
ISOPROPYL ALCOHOL
PEG-75 LANOLIN
WATER
LAURAMINE OXIDE
TRIDECYL ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0116-1061-04 118 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019125
Part 3 of 3
POVIDONE-IODINE PREP PADS MEDIUM
povidone-iodine cloth
Product Information
Item Code (Source) NDC:53329-941
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POVIDONE-IODINE (IODINE) IODINE 10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS
CITRIC ACID MONOHYDRATE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53329-941-09 1 mL in 1 PACKET None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 10/12/2021
Labeler — Oaklock, LLC (079559179)

Revised: 10/2021 Oaklock, LLC

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