ANTISEPTIC SKIN CLEANSER description, usages, side effects, indications, overdosage, supplying and lots more!

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ANTISEPTIC SKIN CLEANSER

Cardinal Health
Xttrium Laboratories, Inc.

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredient

Chlorhexidine Gluconate 4% Solution

Purpose

Antiseptic

Uses

  • healthcare personnel handwash: helps reduce bacteria that potentially can cause disease
  • patient preoperative skin preparation: for the preparation of the patient's skin prior to surgery
  • skin wound and general skin cleansing

Warnings

For external use only

Do not use

  • if you are allergic to chlorhexidine gluconate or any other ingredients
  • in contact with meninges
  • in the genital area
  • as a preoperative skin preparation of the head or face

When using this product

  • keep out of eyes, ears, and mouth. May cause serious and permanent eye injury if placed or kept in the eye during surgical procedures or may cause deafness when instilled in the middle ear through perforated eardrums.
  • if solution should contact these areas, rinse out promptly and thoroughly with water
  • wounds which involve more than the superficial layers of the skin should not be routinely treated
  • repeated general skin cleansing of large body areas should not be done except when the underlying condition makes it necessary to reduce the bacterial population of 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

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Healthcare personnel handwash:

  • wet hands with water
  • dispense about 5 ml of product into cupped hands and wash in a vigorous manner for about 15 seconds
  • rinse and dry thoroughly

Patient preoperative skin preparation:

  • apply product liberally to surgical site and swab for at lease 2 minutes
  • dry with a sterile towel
  • repeat the procedure for an additional 2 minutes and dry with a sterile towel

Skin wound and general skin cleansing:

  • throughly rinse the area to be cleaned with water
  • apply the minimum amount of the product necessary to cover the skin and wound area and wash gently
  • rinse again and thoroughly

Other information

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

Inactive ingredients

Cocamide DEA, Fragrance, Glucono-delta-lactone, Hydroxyethylcellulose, Isopropyl Alcohol, Lauramine Oxide, PEG-75 Lanolin, Purified Water, Tridecyl Alcohol

Questions or comments?

call 1-800-587-3721 CST, Monday through Friday 8:00 AM to 4:30 PM

Principal Display

NDC 37205-595-34

Leader®

Antiseptic Skin Cleanser

(Chlorhexidine Gluconate 4% Solution)

Antiseptic/Antimicrobial Skin Cleanser

For External Use Only

8FL OZ (237mL)

Distributed By Cardinal Health

Dublin, Ohio 43017

CIN 4530226

www.myleader.com

1-800-200-6313

4LEADERBTLLBL

All Leader® Brand products are 100% satisfaction guaranteed or return to place of purchase for a full refund.

Principal Display Principal Display

Principal Display Principal Display

ANTISEPTIC SKIN CLEANSER

CHLORHEXIDINE GLUCONATE LIQUID

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:37205-595
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
chlorhexidine gluconate CHLORHEXIDINE 4 mg

Inactive Ingredients

Ingredient Name Strength
Coco Diethanolamide
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)
ISOPROPYL ALCOHOL
water
TRIDECYL ALCOHOL
GLUCONOLACTONE
PEG-75 LANOLIN

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:37205-595-34 237 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019125 2012-01-01


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