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NDC 49348-0115-37 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 Strategic Sourcing Services, LLC. The primary component is CHLORHEXIDINE GLUCONATE.

Product Information

NDC	49348-0115
Product ID	49348-115_b2bcd6dc-84f3-fb0a-e053-2995a90ac62d
Associated GPIs	92100030102020
GCN Sequence Number	007254
GCN Sequence Number Description	chlorhexidine gluconate LIQUID 4 % TOPICAL
HIC3	Q5B
HIC3 Description	TOPICAL PREPARATIONS,ANTIBACTERIALS
GCN	30011
HICL Sequence Number	004297
HICL Sequence Number Description	CHLORHEXIDINE GLUCONATE
Brand/Generic	Generic
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	Strategic Sourcing Services, 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 49348-0115-37 (49348011537)

Pricing Information
NDC Package Code	49348-115-37
Billing NDC	49348011537
Package	237 mL in 1 BOTTLE, PLASTIC (49348-115-37)
Marketing Start Date	2014-02-20
NDC Exclude Flag	N
Price Per Unit	0.02542
Pricing Unit	ML
Effective Date	2024-02-21
NDC Description	SM ANTISEPTIC SKIN CLEANSER 4%
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1, 5, 6
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 1223185b-c94c-5a9a-e054-00144ff88e88 Details

Active Ingredients

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 are allergic to chlorhexidine gluconate or any other ingredient
in contact with meninges
in 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 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 5ml of product into cupped hands and wahs in vigorous manner for about 15 seconds
rinse and dry thoroughly

Skin wound and normal 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, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol.

Questions of comments?

call 1-800-587-3721 Monday through Friday 8 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.

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

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

PRINCIPAL DISPLAY PANEL

sunmark

Compare to the active ingredient in Hibiclens®

NDC 49348-115-37

antiseptic skin cleanser

Chlorhexidine Gluconate 4% Solution

Antiseptic/Antimicrobial

Skin Cleanser

Dye free

FOR EXTERNAL USE ONLY

NET CONTENTS: 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:49348-115
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:49348-115-37	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/20/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA019125	02/20/2014

Labeler - Strategic Sourcing Services, LLC (116956644)

Registrant - Xttrium Laboratories, Inc. (007470579)

Name	Address	ID/FEI	Business Operations
Establishment
Xttrium Laboratories, Inc.		007470579	manufacture(49348-115)

Revised: 10/2020

Document Id: b2bcd6dc-84f3-fb0a-e053-2995a90ac62d

Set id: 1223185b-c94c-5a9a-e054-00144ff88e88

Version: 5

Effective Time: 20201028