Label: CLX DERM- chlorhexidine gluconate shampoo
- NDC Code(s): 86127-001-01
- Packager: Nextmune AB
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated January 11, 2022
If you are a consumer or patient please visit this version.
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- VETERINARY INDICATIONS
- SAFE HANDLING WARNING
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Properties:
ClxDerm™ 4% chlohexidine digluconate antiseptic shampoo designed for cleansing the skin of dogs and cats. Chlorhexidine, the active ingredient in ClxDerm™ shampoo 4%, has been proven effective against a broad-spectrum of micro-organisms sensitive to chlorhexidine. The use of ClxDerm™ 4% chlohexidine digluconate antiseptic shampoo will aid in the management of skin infections, supporting a healthy skin barrier.
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DOSAGE & ADMINISTRATION
Directions for use: Wet your pet with warm water and apply shampoo. Massage into wet haircoat. Allow to remain on haircoat for 5-10 minutes before rinsing thoroughly with clean water. Repeat as needed. To improve skin condition, shampoo 1 to 2 times per week in a 1 to 2 week period, or as directed by your veterinarian. To maintain healthy skin, shampoo at least once per month or as directed by your veterinarian.
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Precautionary statements:
For external use on dogs and cats only. May cause skin or eye irritation. Avoid getting shampoo in your pet's eyes. In case of contact with eyes, rinse thoroughly with water and consult a veterinarian. If skin irritation occurs and persists, discontinue use and contact your veterinarian. Consult a veterinarian before using on pregnant, lactating or breeding animals; puppies; kittens; or animals with a pre-existing medical condition. Use with caution in older animals. If an animal has an adverse reaction to treatment, discontinue use and contact your veterinarian.
- STORAGE AND HANDLING
- Composition:
- Indications:
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SPL UNCLASSIFIED SECTION
www.icfpet.com
Manufacturer:
iCF™
Evolution of
Knowledgea division of nextmune
NEXTMUNE ITALY S.R.L.
Via G.B. Benzoni, 50 - 26020
PALAZZO PIGNANO (CR) Italy
Tel. +39 0373 982024;
+39 0373 938345
e-mail:info@icfsrl.it
customercare@drnsrl.itDistributor:
Nextmune US, LLC
2801 S. 35th St.,
Phoenix, AZ 85034
480-464-8971made
in Spain - PRINCIPAL DISPLAY PANEL - 250 ml Bottle Carton
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INGREDIENTS AND APPEARANCE
CLX DERM
chlorhexidine gluconate shampooProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:86127-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE 40 mg in 1 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) glycerin (UNII: PDC6A3C0OX) propylene glycol (UNII: 6DC9Q167V3) GUARAPROLOSE (3500 MPA.S AT 1%) (UNII: 3A1I7376TC) isodecyl alcohol (UNII: 3160X491M7) PEG-75 Lanolin (UNII: 09179OX7TB) TROMETHAMINE (UNII: 023C2WHX2V) EDETATE SODIUM (UNII: MP1J8420LU) MYRISTAMINE OXIDE (UNII: J086PM3RRT) LAURAMINE OXIDE (UNII: 4F6FC4MI8W) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:86127-001-01 1 in 1 CARTON 1 250 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 01/01/2021 Labeler - Nextmune AB (352950223) Establishment Name Address ID/FEI Business Operations NEXTMUNE Italy SRL 435856461 MANUFACTURE Establishment Name Address ID/FEI Business Operations Medichem SA 464043381 API MANUFACTURE