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NDC 00116-2800-08 Antiseptic Skin Cleanser 2 mg/100mL Details

Antiseptic Skin Cleanser 2 mg/100mL

Antiseptic Skin Cleanser is a TOPICAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Xttrium Laboratories, Inc.. The primary component is CHLORHEXIDINE GLUCONATE.

Product Information

NDC	00116-2800
Product ID	0116-2800_b1bc2086-5f5f-29b5-e053-2995a90ad40f
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	Exidine-2 CHG
Non-Proprietary Name	CHLORHEXIDINE GLUCONATE
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	TOPICAL
Active Ingredient Strength	2
Active Ingredient Units	mg/100mL
Substance Name	CHLORHEXIDINE GLUCONATE
Labeler Name	Xttrium Laboratories, Inc.
Pharmaceutical Class	Decreased Cell Wall Integrity [PE]
DEA Schedule	n/a
Marketing Category	NDA
Application Number	NDA019422
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00116-2800-08 (00116280008)

Pricing Information	N/A
NDC Package Code	0116-2800-08
Billing NDC	00116280008
Package	250 mL in 1 BOTTLE, PUMP (0116-2800-08)
Marketing Start Date	2016-07-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 468ae2b4-b2b6-19d8-e054-00144ff88e88 Details

Active ingredient

chlorhexidine gluconate 2% 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

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 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
do not use routinely if you have wounds which involve more than 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.

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

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 for 30 seconds. Clean fingernails using a nailstick or similar cleaner.
scrub for 1.5 minutes with about 8 mL of product with or without a wet brush paying close attention to the nails, cuticles, and skin between the fingers
rinse thoroughly under running water for 30 seconds
wash for an additional 1.5 minutes with 8 mL of product and rinse under running water for 30 seconds
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

Other information

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

Inactive ingredients

citric acid, cocamide DEA, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, purified water

Questions or comments?

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

SPL UNCLASSIFIED SECTION

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

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

Package Label

NDC 63868-280-02

Chlorhexidine Gluconate 2% Solution

Antiseptic

Distributed by:

C,D,M,A,Inc.

Novi, MI 48376 USA

qualitychoice.com

2QC02BTLLBLB

Quality Choice ®

Net Wt 2 fl oz (60 mL)

NDC 63868-280-08

QUALITY CHOICE

Antiseptic Skin Cleanser

Antiseptic/Antimicrobial Skin Cleaner

Chlorhexidine Gluconate 2% Solution

Reduces Bacteria on the Skin

FOR EXTERNAL USE ONLY

TRICLOSAN FREE

FDA APPROVED

8.5 fl oz (250 mL)

2QC85BTLLBLFB

INGREDIENTS AND APPEARANCE

ANTISEPTIC SKIN CLEANSER EXIDINE-2 CHG

chlorhexidine gluconate solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0116-2800
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	2 mg in 100 mL

Ingredient Name	Strength
Inactive Ingredients
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
WATER (UNII: 059QF0KO0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0116-2800-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2016	02/29/2020
2	NDC:0116-2800-08	250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/01/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA019422	07/01/2016

Labeler - Xttrium Laboratories, Inc. (007470579)

Registrant - Xttrium Laboratories, Inc. (007470579)

Name	Address	ID/FEI	Business Operations
Establishment
Xttirum Laboratories, Inc.		007470579	manufacture(0116-2800)

Revised: 10/2020

Document Id: b1bc2086-5f5f-29b5-e053-2995a90ad40f

Set id: 468ae2b4-b2b6-19d8-e054-00144ff88e88

Version: 14

Effective Time: 20201015