Label: PRE-SCRUB II SURGICAL HAND SCRUB- chlorhexidine gluconate solution solution
-
Contains inactivated NDC Code(s)
NDC Code(s): 22884-8103-1, 22884-8103-8 - Packager: BioMed Systems, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated December 28, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
Warnings
For external use only
____________________________________________________________________
Allergy alert:
This product may cause a severe allergic reaction. Symptoms may include:
- wheezing/difficulty breathing
- shock
- facial swelling
- hives
- rash
If an allergic reaction occurs, stop use and seek medical help right away.
____________________________________________________________________
Do not use
- If you are allergic to chlorhexidine gluconate or any other ingredient in this
product
____________________________________________________________________
When using this product
- keep out of eyes, ears, and mouth. May cause serious and permanent eye injury
if permitted to enter or allowed to remain.
- if contact occurs, rinse with cold water right away
- do not use routinely if you have wounds which involve more thank the superficial
layers of the skin
____________________________________________________________________
Stop use and ask a doctor if irritation, sensitization, or allergic reaction occurs.
These may be signs of a serious condition.
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions
• Use with care in Premature infants under 2 months of age. These
products may cause irritation or chemical burns.
• open package
• wet hands and forearms to the elbows with warm water
• clean under nails with nail pick provided. Nails should be maintained
with a 1 millimeter free edge
• wet sponge and squeeze to work up lather
• scrub thoroughly for 3 minutes. Paying particular attention to the
nails, cuticles and interdigital spaces. Use the brush side to clean the
nails, cuticles and interdigital spaces between the fingers and the
sponge side to scrub the hands and forearms
• rinse thoroughly with warm water
• scrub for an additional 3 minutes using the sponge side
• discard brush-sponge
• rinse hands and forearms thoroughly and dry with a sterile towel.
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
PRE-SCRUB II SURGICAL HAND SCRUB
chlorhexidine gluconate solution solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:22884-8103 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE 1 mg in 25 mL Inactive Ingredients Ingredient Name Strength COCO DIETHANOLAMIDE (UNII: 92005F972D) GLUCONOLACTONE (UNII: WQ29KQ9POT) ISOPROPYL ALCOHOL (UNII: ND2M416302) LAURAMINE OXIDE (UNII: 4F6FC4MI8W) POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) LANOLIN (UNII: 7EV65EAW6H) WATER (UNII: 059QF0KO0R) TRIDECYL ALCOHOL (UNII: 8I9428H868) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:22884-8103-8 30 in 1 CARTON 03/01/1989 1 NDC:22884-8103-1 25 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA019822 03/01/1989 Labeler - BioMed Systems, Inc. (622463388) Registrant - K. W. Griffen Company (622463388) Establishment Name Address ID/FEI Business Operations Bajaj Medical LLC 078774921 manufacture(22884-8103) Establishment Name Address ID/FEI Business Operations BioMed Systems 622463388 relabel(22884-8103) , repack(22884-8103)