HEALTHY PAW LIFE PET SKIN CLEANSER: Product Information

HEALTHY PAW LIFE PET SKIN CLEANSER- calcium polysulfide spray
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.

OUR FORMULA Seborrheic dermatitis is most commonly caused by bacteria or fungus. Sulfur in our formula provides relief of symptoms caused by seborrheic dermatitis while Aloe Vera moistures skin and promotes healing. Use our formulation on dogs and cats suffering from demodectic or sarcoptic mange mites.

INGREDIENTS Water, Aloe Vera, Alcohol, Glycerin, CocoGlucoside, Cedarwood Oil, Rose Oil, Calcium Polvsulfide (Sulfur).

Warning: Keep out of reach of children. May stain skin, light colored animals, clothing and porous surfaces. May have high odor — use in well ventilated areas. Wear safety glasses.

Caution: For topical use only. Avoid contact with eyes and mucous membranes. If skin irritation develops, rinse applied area with 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 fluids.
DO NOT INDUCE VOMITING.

DIRECTIONS & INSTRUCTIONS
1. Bathe your pet the day before you apply Healthy Paw Life’s Pet Skin
Cleanser.
2. Gently clean debris and excess drainage from the affected area with a soft, clean towel.
3. Shake bottle well, and holding bottle upright, spray affected area(s) generously ensuring to bypass the fur and saturate the skin. Ensure to avoid eyes, mouth, genitals and other sensitive areas. Do not allow your pet to ingest or lick.
4. Allow the sprayed areas to dry.
Do not allow animal to lick the area.
5. Repeat steps three and four every other day for one week, then once per week until no longer needed.

MANUFACTURED FOR:
Classic Agrimed LLC

HEALTHY PAW LIFE PET SKIN CLEANSER pet skin cleanser spray

Product Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:86130-900 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM POLYSULFIDE (CALCIUM HYDROXIDE and SULFUR) CALCIUM HYDROXIDE 0.49 g in 100 g

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:86130-900-08 236 g in 1 BOTTLE, SPRAY 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