SMILING PAWS PETS- chlorhexidine ,ketoconazole cloth

Drug Labeling and Warnings

Drug Details [pdf]

Active ingredients (per wipe) 

Chlorhexidine 2% and Ketoconazole 1%

Purpose

Antibacterial and Antifungal medicated wipes

Uses

Our medicated wipes provide veterinary-strength treatment for yeast, bacteria, acne, fungus, pyoderma, and ringworm, while being gentle on the skin. They are specially formulated for the antiseptic cleansing of skin folds, paws, underarms, and groin areas, helping your pet look and feel their best.

Warning

Avoid contact with eyes and mucous membranes. In case of contact, rinse thoroughly with water and consult a veterinarian. If skin irritation develops or worsens, discontinue use and seek veterinary advice.

Direction

Thoroughly wipe the affected area with a pad 1 to 3 times daily, or as directed by your veterinarian. Do not allow your pet to lick the treated area; use a protective collar if necessary to prevent ingestion. Each wipe is intended for single use only—do not reuse. Avoid use on open wounds, cuts, or raw skin.

Inactive ingredients

Water, Propylene Glycol, Nonoxynol-9, Lactic Acid, Polysorbate 20, Aloe Barbadensis (Aloe) Leaf Juice, Glycerine, Fragrance, Methylisothiazolinone

Other information

Store at room temperature. Protect from freezing.

Product label

INGREDIENTS AND APPEARANCE

SMILING PAWS PETS 
chlorhexidine ,ketoconazole cloth

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 86255-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORHEXIDINE (UNII: R4KO0DY52L) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE	2 g  in 100 g
KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I)	KETOCONAZOLE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
NONOXYNOL-9 (UNII: 48Q180SH9T)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 86255-001-01	50 in 1 JAR
1		0.03 g in 1 PATCH
2	NDC: 86255-001-02	50 in 1 JAR
2		0.03 g in 1 PATCH
3	NDC: 86255-001-03	50 in 1 JAR
3		0.03 g in 1 PATCH

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/01/2024

Labeler - Smiling Paws Pets LLC (838142813)

Establishment
Name	Address	ID/FEI	Business Operations
Tropichem Research Labs, LLC dba Vetio		603123068	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Garonit Pharmaceutical, Inc.		800875106	api manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Unilab Chemicals and Pharmaceuticals Private Limited		915893696	api manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Cadila Pharmaceuticals Limited		916130698	api manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Piramal Pharma Limited		919067108	api manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Sharon Bio-Medicine Limited		675472749	api manufacture