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NDC 46122-0137-43 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 AmerisourceBergen Drug Corporation. The primary component is CHLORHEXIDINE GLUCONATE.

Product Information

NDC	46122-0137
Product ID	46122-137_7e7c3128-d19d-8a4a-e053-2991aa0a770e
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	AmerisourceBergen Drug Corporation
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 46122-0137-43 (46122013743)

Pricing Information
NDC Package Code	46122-137-43
Billing NDC	46122013743
Package	473 mL in 1 BOTTLE (46122-137-43)
Marketing Start Date	2019-01-01
NDC Exclude Flag	N
Price Per Unit	0.02322
Pricing Unit	ML
Effective Date	2023-12-20
NDC Description	GNP ANTISEPTIC SKIN CLEANSR 4%
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	4, 5
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 12ace9af-14ed-2dea-e054-00144ff8d46c Details

Active Ingredients

Chlorhexidine Gluconate 4% Solution

Purpose

Antiseptic

Uses

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 cuase 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 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 cuase 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 healthcare provider

Directions

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

Healthcare personnel handwash:

wet hands with water
dispense about 5ml of product into cupped hands and wash 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, 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 contains a chemical (cocamide DEA) 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 only non-chlorine detergents.

*Good Neighbor Pharmacy® Antiseptic Skin Cleanser is not manufactured or distributed by Mölnlycke Healthcare, owner of the registered trademark Hibiclens®.

Package label and principal display panel

Good Neighbor Pharmacy

NDC 46122-137-34

Antiseptic Skin Cleanser

(Chlorhexidine Gluconate 4% solution)

Antiseptic/Antimicrobial Skin Cleanser

8 FL OZ. (237 mL)

ABC# 10103514

FOR EXTERNAL USE ONLY

DYE FREE

TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING

Good Neighbor Pharmacy

Compare to the active ingredient in Hiniclens®*

NDC 46122-137-43

Antiseptic Skin Cleanser

(CHLORHEXIDINE GLUCONATE 4% SOLUTION)

ANTISEPTIC/ANTIMICROBIAL SKIN CLEANSER

16 fl oz (473 mL)

ABC# 815811