CALENDULA OFFICINALIS- calendula officinalis flowering top liquid

Calendula officinalis by

Drug Labeling and Warnings

Calendula officinalis by is a Homeopathic medication manufactured, distributed, or labeled by Heavenly Herbals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Calendula Officinalis Ø=1X
Calendula Officinalis Flowering Top)

Purpose

Promotes the healing of injured skin.

Dosage

Unless otherwise prescribed, adults take 5-10 drops mixed with water, 2-3 times daily. For children under the age of 12, consult your physician.

Indications

Promotes the healing of injured skin.

Warning and Precautions

Contact physician if symptoms persist or worsen.

if pregnant or breast-feeding, consult a health professional before use.

In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

Store at room temperature.

Protect from direct sun-light and heat.

Particulate matter is common in the extract.

Children

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

Do Not Use

Do not use this product if clear shrink band is missing.

Inactive Ingredients

Alcohol 45% by volume.

Warning

Contact physician if symptoms persist or worsen.

if pregnant or breast-feeding, consult a health professional before use.

In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

Store at room temperature.

Protect from direct sun-light and heat.

Particulate matter is common in the extract.

Packaging Label

INGREDIENTS AND APPEARANCE

CALENDULA OFFICINALIS 
calendula officinalis flowering top liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84292-270
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)	CALENDULA OFFICINALIS FLOWERING TOP	1 [hp_X]  in 60 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)	45 mL  in 60 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84292-270-01	60 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	01/23/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/23/2021

Labeler - Heavenly Herbals, Inc. (105609629)

Registrant - Heavenly Herbals, Inc. (105609629)

Establishment
Name	Address	ID/FEI	Business Operations
Heavenly Herbals, Inc.		105609629	manufacture(84292-270)