CLASSIC LIME SULFUR DIP: Product Information

CLASSIC LIME SULFUR DIP- calcium polysulfide liquid
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.

Classic Lime Sulfur Dip Label

Ingredients:
Sulfurated Lime Solution…..(97.8%)
Inert Ingredients…..2.2%

Description:
Lime Sulfur Dip is a sulfur concentrate for treatment of non specific dermatitis and parasites on dogs, cats, puppies and kittens who are responsive to lime sulfur.

Dilution:
Shake concentrate well. Add 4 oz of concentrate to 1 gallon of water. After adding concentrate to water, mix well. For chronic or resistant cases, concentrate may be diluted up to 8 oz. per gallon of water.

Directions
Wear gloves and safety glasses. Carefully pour diluted dip over the affected areas. Alternatively, sponge or dip the affected areas. Re apply every 5 to 7 days or as directed by your veterinarian.
Do not rinse or blow dry the animal. For topic use only. Do not allow animal to ingest and ensure it does not enter body cavities. Apply a protective collar until dry and to prevent ingestion.

Storage:
Store at controlled room temperature. If a crust or precipitate forms, immerse closed container in warm water for 15 minutes, shake well, and use according to direction. Do not reuse empty container.

Warning:
Must be diluted before use.
Keep out of reach of children.
May stain skin, light colored animals, clothing and porous (i.e. cement) surfaces. Will change the color of jewelry.
Use in well ventilated area.
Wear safety glasses.

Caution:
For topical use only on dogs and cats. Do not exceed recommended daily concentration. Measure carefully. Avoid contact with eyes and mucous membranes. May cause skin irritation. If eye contact or skin irritation develops, rinse with clean water for at least 15 minutes, stop treatment and contact your veterinarian immediately. If ingestion occurs, rinse mouth with clean water and offer large amount of milk, egg whites or water.

DO NOT INDUCE VOMITING

Manufactured For:
Classic Agrimed LLC

CLASSIC LIME SULFUR DIP lime sulfur liquid

Product Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:86130-100 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM POLYSULFIDE (LIME (CALCIUM OXIDE) and SULFUR) CALCIUM POLYSULFIDE 25 g in 100 mL

Inactive Ingredients Ingredient Name Strength WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:86130-100-04 119 mL in 1 CONTAINER None 2 NDC:86130-100-08 237 mL in 1 CONTAINER None 3 NDC:86130-100-12 355 mL in 1 CONTAINER None 4 NDC:86130-100-16 444 mL in 1 CONTAINER None 5 NDC:86130-100-28 3785 mL in 1 CONTAINER None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 08/29/2020

Labeler — CLASSIC AGRIMED LLC (057659176)

Registrant — CLASSIC AGRIMED LLC (057659176)

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

Revised: 05/2023 CLASSIC AGRIMED LLC