Label: CLX DERM SPOT- chlorhexidine gluconate gel
- NDC Code(s): 86127-004-03
- Packager: Nextmune AB
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated January 12, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- VETERINARY INDICATIONS
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
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PRECAUTIONS
Precautionary statements:
For external use on dogs and cats only. May cause skin or eye irritation. Avoid getting gel 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. Do not use inside the ear canal. If an animal has an adverse reaction to treatment, discontinue use and contact your veterinarian.
- SAFE HANDLING WARNING
- STORAGE AND HANDLING
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SPL UNCLASSIFIED SECTION
Manufacturer:
iCF™
Evolution of
Knowledgea division of
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 SpainiCF™
Evolution of
Knowledgewww.icfpet.com
- PRINCIPAL DISPLAY PANEL - 100 ml Bottle Carton
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INGREDIENTS AND APPEARANCE
CLX DERM SPOT
chlorhexidine gluconate gelProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:86127-004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE 4.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) glycerin (UNII: PDC6A3C0OX) GUARAPROLOSE (3500 MPA.S AT 1%) (UNII: 3A1I7376TC) isodecyl alcohol (UNII: 3160X491M7) Sorbitol (UNII: 506T60A25R) PEG-75 Lanolin (UNII: 09179OX7TB) TROMETHAMINE (UNII: 023C2WHX2V) EDETATE SODIUM (UNII: MP1J8420LU) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:86127-004-03 1 in 1 CARTON 1 100 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