Antiseptic skin cleanser liquid

Active ingredient

Chlorhexidine Gluconate 4% Solution

Purpose

Antiseptic

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 or the patient is allergic to chlorhexidine gluconate or any other ingredient in this product
  • in contact with meninges
  • in the genital area

Keep out of reach of children.

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

Stop use and ask a doctor if

irritation, sensitization or allergic reaction occurs. These may be signs of a serious condition.

When using this product

  • keep out of eyes, ears, and mouth. May cause serious and permanent eye injury if permitted to enter and remain in the eye 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 advised by a health care provider

Directions

use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.

Surgical hand scrub

  • wet hands and forearms under running water
  • scrub for 3 minutes with about 5 mL of product and a wet brush, paying close attention to the nails, cuticles, and interdigital spaces
  • a separate nail cleaner may be used
  • rinse thoroughly
  • wash for an additional 3 minutes with 5 mL of product and rinse under running water
  • dry thoroughly

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

Skin wound and general skin cleansing:

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

Other information

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

Inactive ingredients

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

Questions of comments?

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

Ingredients and appearance - Product information

Antiseptic skin cleanser liquid- Chlorhexidine gluconate 4%

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 36800-401
Route of Administration Topical

Active Ingredient/Active Moiety

Ingredient Name Strength
Chlorhexidine gluconate ( UNII: MOR84MUD8E)( Chlorhexidine - UNII: R4KO0DY52L ) 4 mgin 100 mL

Inactive Ingredients

Ingredient Name Code
Coco diethanolamide ( UNII: 92005F972D)
Peg-75 lanolin ( UNII: 09179OX7TB)
Hydroxyethyl cellulose (2000 cps at 1%) ( UNII: S38J6RZN16)
Isopropyl alcohol ( UNII: ND2M416302)
Water ( UNII: 059QF0KO0R)
Tridecyl alcohol ( UNII: 8I9428H868)
Gluconolactone ( UNII: WQ29KQ9POT)

Product Characteristics

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 36800-401-50 237mL in 1 BOTTLE, PLASTIC 2013/11/01

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
NDA NDA019125 USA 2013/11/01

Labeler - Topco Associates LLC( 006935977)

Establishment

Name ID/FEI Business Operations
Topco Associates LLC 006935977 manufacture( 36800-401)

Package label and principal display panel

NDC 36800-401-50

TopCare® health™

COMPARE TO HIBICLENS® ACTIVE INGREDIENT*

DYE FREE

Antiseptic Skin Cleanser

(CHLORHEXIDINE GLUCONATE 4% SOLUTION)

ANTISEPTIC / ANTIMICROBIAL SKIN CLEANSER

FOR EXTERNAL USE ONLY

8 FL OZ (237 mL)