CALENDULA SP: Product Information

CALENDULA SP- calendula officinalis seed oil and 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.

Ingredients: Calendula Oil, Lime Sulfur Concentrate, Aloe Vera, Lavender Oil, Fragrance, Glycerin, Soothing Lotion Base

Directions For Use: Shake well before use. Hold spray 4 to 6 inches away and apply directly to affected area. Spray affected areas 2 to 3 times daily or as directed by veterinarian.

Do not use in areas if pus is present. For short term use only. After using the product as directed, if conditions does not improve in 7 to 10 days, consult your veterinarian. Not for prolonged use.

Store at room temperature.

Read entire label before each use. Use only in accordance with labeled instructions.

Caution:

Keep out of reach of children.
For animal and topical use only. Do not spray in the face, eyes, genitals or mucous membranes. Do not allow pet to ingest. If irritation, redness, inflammations or swelling develops or persists, discontinue use immediately and consult your veterinarian.

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CALENDULA SP
calendula sp liquid
Product Information
Product Type OTC ANIMAL DRUG Item Code (Source) NDC:86130-201
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALENDULA OFFICINALIS SEED OIL (CALENDULA OFFICINALIS SEED OIL) CALENDULA OFFICINALIS SEED OIL 1 g in 100 mL
CALCIUM POLYSULFIDE (CALCIUM HYDROXIDE and SULFUR) CALCIUM POLYSULFIDE 0.7 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
aloe
WATER
COCONUT OIL
LAVENDER OIL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:86130-201-04 118 mL in 1 CONTAINER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 04/23/2023
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

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