OTC Medication Information: Antiseptic Skin Cleanser

ANTISEPTIC SKIN CLEANSER- chlorhexidine gluconate liquid
Topco Associates LLC

Active Ingredient

Chlorhexidine Gluconate 4% Solution

Purpose

Antiseptic

Uses

  • surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care
  • healthcare personnel handwash: helps reduce bacteria that potentially can cause disease
  • skin wound and general skin cleansing

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

Inactive ingredients

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

Questions of comments?

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

Warning: This product can expose you to coconut oil diethanolamine condensate (cocamide diethanolamine), which is known to the State of California to cause cancer. For more information go to www.P65Warnings.gov

Laundering/Cleaning Instructions: Chlorhexidine gluconate skin cleansers will cause stains if used with chlorine releasing products. Rinse completely and use only non-chlorine detergents.

*This product is not manufactured or distributed by Mölnlycke Healthcare, owner of the registered trademark Hibiclens®.

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)

TOPCO08 PDP
(click image for full-size original)
TOPCO08 DF1
(click image for full-size original)
TOPCO08 DF2
(click image for full-size original)
TOPCO08 DF3
(click image for full-size original)
ANTISEPTIC SKIN CLEANSER
chlorhexidine gluconate 4% liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-401
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORHEXIDINE GLUCONATE (CHLORHEXIDINE) CHLORHEXIDINE GLUCONATE 4 mg in 100 mL
Inactive Ingredients
Ingredient Name Strength
COCO DIETHANOLAMIDE
PEG-75 LANOLIN
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)
ISOPROPYL ALCOHOL
WATER
TRIDECYL ALCOHOL
GLUCONOLACTONE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36800-401-50 237 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019125 11/01/2013
Labeler — Topco Associates LLC (006935977)
Registrant — Xttrium Laboratories, Inc. (007470579)
Establishment
Name Address ID/FEI Operations
Xttrium Laboratories, Inc. 007470579 manufacture (36800-401)

Revised: 06/2019 Topco Associates LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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