CALENDULA SP by CLASSIC AGRIMED LLC CALENDULA SP liquid

CALENDULA SP by

Drug Labeling and Warnings

CALENDULA SP by is a Animal medication manufactured, distributed, or labeled by CLASSIC AGRIMED LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CALENDULA SP 
calendula sp liquid

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 86130-201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALENDULA OFFICINALIS SEED OIL (UNII: 9JS8DS42SV) (CALENDULA OFFICINALIS SEED OIL - UNII:9JS8DS42SV)	CALENDULA OFFICINALIS SEED OIL	1 g  in 100 mL
CALCIUM POLYSULFIDE (UNII: 87N1QVL75L) (CALCIUM HYDROXIDE - UNII:PF5DZW74VN, SULFUR - UNII:70FD1KFU70)	CALCIUM POLYSULFIDE	0.7 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
aloe (UNII: V5VD430YW9)
WATER (UNII: 059QF0KO0R)
COCONUT OIL (UNII: Q9L0O73W7L)
LAVENDER OIL (UNII: ZBP1YXW0H8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 86130-201-04	118 mL in 1 CONTAINER

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	Business Operations
CLASSIC AGRIMED LLC		057659176	manufacture, api manufacture