BM CALENDULA- calendula officinalis ointment

BM Calendula by

Drug Labeling and Warnings

BM Calendula by is a Homeopathic medication manufactured, distributed, or labeled by BM Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INACTIVE INGREDIENT

Inactive Ingredients:

Cetostearyl alcohol, Paraffin oil, White soft paraffin, Jasmine Fragrance

ACTIVE INGREDIENT

Active ingredients

Aloe Vera Ø (HPUS)

Calendula Ø (HPUS)

Chamomilla Ø (HPUS)

INDICATIONS & USAGE

Uses*

Helps temporarily relieve: skin irritation, rash, redness, minor wounds and burns, minor skin allergy

PURPOSE

Active ingredients Purpose*

Aloe Vera Ø (HPUS)……………. minor burns & skin irritation

Calendula Ø (HPUS)……………minor cuts & scrapes

Chamomilla Ø (HPUS)…………….itching & irritation

DOSAGE & ADMINISTRATION

Directions:

Use as directed.

Clean the affected area before application.

Apply a thin layer to the affected area, 2-3 times daily or as directed by a physician.

WARNINGS

Warnings:

For external use only.

Avoid contact with eyes and mucous membranes.

Keep out of reach of children.

If you have severe symptoms, consult a doctor before use.

Do not use on deep and puncture wounds, severe burns, and infected skin.

KEEP OUT OF REACH OF CHILDREN

Warnings:

Keep out of reach of children.

STORAGE AND HANDLING

Storage:

Store in a cool, dry place below 30°C (86°F).

Protect from direct sunlight.

PRINCIPAL DISPLAY PANEL

Tube

Carton Box

INGREDIENTS AND APPEARANCE

BM CALENDULA 
calendula officinalis ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85816-6021
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X) (ALOE VERA LEAF - UNII:ZY81Z83H0X)	ALOE VERA LEAF	1 [hp_X]  in 1 g
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)	CALENDULA OFFICINALIS FLOWERING TOP	1 [hp_X]  in 1 g
CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X)	CHAMOMILE	1 [hp_X]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)	0.0025 g  in 1 g
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)	0.095 g  in 1 g
MINERAL OIL (UNII: T5L8T28FGP)	0.04 g  in 1 g
WHITE PETROLATUM (UNII: B6E5W8RQJ4)	0.8625 g  in 1 g

Product Characteristics
Color	brown (yellowish brown)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85816-6021-1	40 g in 1 JAR; Type 6: Drug/Biologic Combination	01/01/2015	10/01/2025
2	NDC: 85816-6021-2	40 g in 1 TUBE; Type 6: Drug/Biologic Combination	10/10/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/01/2015

Labeler - BM Private Limited (645599762)

Establishment
Name	Address	ID/FEI	Business Operations
BM Private Limited		645599762	pack(85816-6021) , manufacture(85816-6021) , label(85816-6021)