ANTISEPTIC SKIN CLEANSER- chlorhexidine gluconate 4% liquid 
Chain Drug Consortium, LLC

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Drug Facts

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 cleaning

Warnings

For external use only

Allergy alert: This product may cause severe allergic reaction. Symptoms may include:

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

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

Stop use and ask 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

Warning

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

Directions

Healthcare personnel handwash:

Skin wound and normal skin cleansing:

Other information

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.

Other Safetly Information

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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.ca.gov.

Distributed By:

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, PA 19087

MADE IN USA

If for any reason you are not satisfied with this product, please return it to the store where purchased for a full refund.

Active ingredient

Chlorhexidine gluconate 4% solution

Purpose

Antiseptic

Uses

Warnings

For external use only

Allergy alert: This product may cuase a severe allergic reaction. Symptoms may include:

If an allergic reaction occurs, stop use and seek medical help right away.

Do not use

When using this product

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

Healthcare personnel handwash:

Skin wound and general skin cleansing:

Other information

Inactive ingredients

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

Questions or comments?

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

Laundering/Cleaning Instructions: Chlorhexidine gluconate skin cleansers will cause stains if used with chlorine releasing products, such as chlorine bleach. 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

Premier Value

COMPARE TO THE ACTIVE INGREDIENT IN HIBICLENS®

Antiseptic Skin Cleanser

Antiseptic/Antimicrobial Skin Cleanser

(Chlorhexidine Gluconate 4% solution)

FOR EXTERNAL USE ONLY

DYE FREE

DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING

8FL OZ. (237 mL)

PV8 PDP

PV8 drug facts 1

PV8 drug facts 2

PV8 drug facts 3

PV8 drug facts 4

Princical Display Panel

Premier Value

COMPARE TO THE ACTIVE INGREDIENT IN HIBICLENS ®*

Antiseptic Skin Cleanser

ANTISEPTIC/ANTIMICROBIAL SKIN CLEANSER

(Chlorhexidine Gluconate 4% Solution)

FOR EXTERNAL USE ONLY

DYE FREE

DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING

16 fl oz (473 mL)

PV16 PDP

PV 16 Drug Facts 1

PV 16 Drug Facts 2

PV16 Drug Facts 3

ANTISEPTIC SKIN CLEANSER 
chlorhexidine gluconate 4% liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-228
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE4 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-228-00237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2019
2NDC:68016-228-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01912510/30/2012
Labeler - Chain Drug Consortium, LLC (101668460)
Registrant - Xttrium Laboratories, Inc. (007470579)
Establishment
NameAddressID/FEIBusiness Operations
Xttrium Laboratories, Inc.007470579manufacture(68016-228)

Revised: 12/2018
Document Id: 7d65ade8-0696-7b74-e053-2a91aa0a580c
Set id: 12af447c-5601-34d2-e054-00144ff8d46c
Version: 4
Effective Time: 20181219
 
Chain Drug Consortium, LLC