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NDC 36800-0401-50 Antiseptic Skin Cleanser 4 mg/100mL Details

Antiseptic Skin Cleanser 4 mg/100mL

Antiseptic Skin Cleanser is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Topco Associates LLC. The primary component is CHLORHEXIDINE GLUCONATE.

Product Information

NDC	36800-0401
Product ID	36800-401_8a6c911b-56f9-0884-e053-2a95a90a5d3c
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Antiseptic Skin Cleanser
Proprietary Name Suffix	n/a
Non-Proprietary Name	Chlorhexidine Gluconate 4%
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	4
Active Ingredient Units	mg/100mL
Substance Name	CHLORHEXIDINE GLUCONATE
Labeler Name	Topco Associates LLC
Pharmaceutical Class	Decreased Cell Wall Integrity [PE]
DEA Schedule	n/a
Marketing Category	NDA
Application Number	NDA019125
Listing Certified Through	2024-12-31

Package

Package Images

NDC 36800-0401-50 (36800040150)

Pricing Information	N/A
NDC Package Code	36800-401-50
Billing NDC	36800040150
Package	237 mL in 1 BOTTLE, PLASTIC (36800-401-50)
Marketing Start Date	2013-11-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a0b7180a-0257-4a64-9d1a-6b6d824fac1c Details

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

SPL UNCLASSIFIED SECTION

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)

INGREDIENTS AND APPEARANCE

ANTISEPTIC SKIN CLEANSER

chlorhexidine gluconate 4% liquid

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	4 mg in 100 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:36800-401-50	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2013

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA019125	11/01/2013

Labeler - Topco Associates LLC (006935977)

Registrant - Xttrium Laboratories, Inc. (007470579)

Name	Address	ID/FEI	Business Operations
Establishment
Xttrium Laboratories, Inc.		007470579	manufacture(36800-401)

Revised: 6/2019

Document Id: 8a6c911b-56f9-0884-e053-2a95a90a5d3c

Set id: a0b7180a-0257-4a64-9d1a-6b6d824fac1c

Version: 5

Effective Time: 20190603