Label: CHLORHEXIDINE GLUCONATE SOLUTION 0.75% ANTISEPTIC solution
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Contains inactivated NDC Code(s)
NDC Code(s): 81657-001-01, 81657-001-02, 81657-001-03, 81657-001-04 - Packager: USA Medical Supply LLC
- This is a repackaged label.
- Source NDC Code(s): 61037-414
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated June 18, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Use
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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.
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
- do not use routinely if you have wounds which involve more than the superficial layers of the skin
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
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Package/Label Principal Display Panel
Dr. Dean
Chlorhexidine Gluconate
Solution
0.75%
Up to 6 Hour Protection
Antimicrobial Skin Soap
FOR EXTERNAL USE ONLY
Distributed by USA Medical Supply
Northbrook, IL 60062
www.usamedicalsupply.com
4 fl oz (118 mL)
NDC 81657-001-01
MADE IN THE USA
FDA APPROVED
California Prop 65 WARNING
Keep from freezing.
Dr. Dean
Chlorhexidine Gluconate
Solution
0.75%
Up to 6 Hour Protection
Antimicrobial Skin Soap
FOR EXTERNAL USE ONLY
Distributed by USA Medical Supply
Northbrook, IL 60062
www.usamedicalsupply.com
8 fl oz (236 mL)
NDC 81657-001-02
MADE IN THE USA
FDA APPROVED
California Prop 65 WARNING
Keep from freezing.
Dr. Dean
Chlorhexidine Gluconate
Solution
0.75%
Up to 6 Hour Protection
Antimicrobial Skin Soap
FOR EXTERNAL USE ONLY
Distributed by USA Medical Supply
Northbrook, IL 60062
www.usamedicalsupply.com
8 fl oz (236 mL)
NDC 81657-001-04
MADE IN THE USA
FDA APPROVED
California Prop 65 WARNING
Keep from freezing.
Dr. Dean
Chlorhexidine Gluconate
Solution
0.75%
Up to 6 Hour Protection
Antimicrobial Skin Soap
FOR EXTERNAL USE ONLY
Distributed by USA Medical Supply
Northbrook, IL 60062
www.usamedicalsupply.com
128 fl oz (3785 mL)
NDC 81657-001-03
MADE IN THE USA
FDA APPROVED
California Prop 65 WARNING
Keep from freezing.
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INGREDIENTS AND APPEARANCE
CHLORHEXIDINE GLUCONATE SOLUTION 0.75% ANTISEPTIC
chlorhexidine gluconate solution 0.75% antiseptic solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81657-001(NDC:61037-414) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE 0.75 mg in 100 mL Inactive Ingredients Ingredient Name Strength COCO DIETHANOLAMIDE (UNII: 92005F972D) HYDROXYETHYL CELLULOSE (140 CPS AT 5%) (UNII: 8136Y38GY5) ISOPROPYL ALCOHOL (UNII: ND2M416302) LAURAMINE OXIDE (UNII: 4F6FC4MI8W) RICINOLEAMIDOPROPYLTRIMONIUM CHLORIDE (UNII: 93OU7D1C3U) WATER (UNII: 059QF0KO0R) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C RED NO. 4 (UNII: X3W0AM1JLX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81657-001-01 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/30/2014 2 NDC:81657-001-02 236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/30/2014 3 NDC:81657-001-03 3785 mL in 1 JUG; Type 0: Not a Combination Product 09/30/2014 4 NDC:81657-001-04 236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 10/12/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020111 09/30/2014 Labeler - USA Medical Supply LLC (117790416)