HEALTHY PAW LIFE ROLLON: Product Information

HEALTHY PAW LIFE ROLLON- calcium polysulfide lotion
CLASSIC AGRIMED LLC

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.

Description:
Lime Sulfur ointment is for non-specific dermatitis and parasites in dogs, cats, puppies, kittens, rabbits and other domesticated animals. Properties of Lime Sulfur help with skin affected by ringworm, mange, scabies and fungus. Essential oils and cream base promote hair growth, relieve dry skin and nourish skin.

Warning:
Keep out of reach of children. Do not allow animal to ingest. Apply a protective collar, if necessary, to prevent ingestion.

Storage:
Store in dry and cool place away from sunlight and extreme temperatures.

Directions:
Roll-on the Lime Sulfur ointment over the affected area until the area is fully covered. Treat once daily for one week then twice per week for two more weeks. If needed, continue to use every week for additional weeks or as directed by your veterinarian. For better results, use in condjuction with our Lime Sulfur Dip, Spray or Shampoo.

Caution:
For topical and external use only. Avoid contact with eyes and mucous membranes. If eye contact or skin irritation develops, rinse the applied area with water for at least 15 minutes. If ingestion occurs, rinse the mouth with clean water and offer large amounts of fluids. Stop treatment and contact your veterinarian.

Ingredients:

Water, Lime Sulfur Concentrate, Aloe Barbadensis, Lavender Oil, Eucalyptus Oil, Sunflower Oil, Coconut Oil, Ceteraryl Alochol & Ceteareth-209, Glycerin/Glycerides, Alkyl Fumarate, Isopropyl Palmitate, Trissopropylamine, Acrylates, Hydantion, Idopropyl Butylcarbamate, Tocopheryl Acetate

Manufactured For: Classic Agrimed LLC

HEALTHY PAW LIFE ROLLON lime sulfur lotion

Product Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:86130-600 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM POLYSULFIDE (CALCIUM HYDROXIDE and SULFUR) CALCIUM HYDROXIDE 0.32 in 100 g

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:86130-600-03 84 g in 1 CONTAINER None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 12/08/2022

Labeler — CLASSIC AGRIMED LLC (057659176)

Registrant — CLASSIC AGRIMED LLC (057659176)

Establishment
Name	Address	ID/FEI	Operations
CLASSIC AGRIMED LLC		057659176	manufacture, api manufacture

Revised: 11/2023 CLASSIC AGRIMED LLC