CALENDULA by Boiron / Boiron Inc. CALENDULA ointment

CALENDULA by

Drug Labeling and Warnings

CALENDULA by is a Homeopathic medication manufactured, distributed, or labeled by Boiron, Boiron Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Calendula Officinalis 1X HPUS

INDICATIONS & USAGE

• Temporarily protects and helps promote healing of minor burns.

DO NOT USE

Do not use

• Over large areas of the body
• If you are allergic to Calendula officinalis or to this product's inactive ingredients.
• Under tight bandages.
• Do not use if glued carton end flaps are broken or if the tube seal is broken.

DOSAGE & ADMINISTRATION

For minor burns, immediately run cool water on the burn for several minutes and dry.

• Then apply a thin layer of Calendula Burn to affected area 3 times a day or as needed.

INACTIVE INGREDIENT

White petrolatum NF

HOW SUPPLIED

Tube 1 OZ (30 G)

PURPOSE

Calendula officinalis 1X ... Healing agent

STORAGE AND HANDLING

QUESTIONS

Questions, Comments?

www.BoironUSA.com
info@boiron.com

1-800-BOIRON-1
(1-800-264-7661)

Distributed by Boiron Inc.
6 Campus Boulevard
Newtown Square, PA
19073-3267

ASK DOCTOR

Ask a doctor before use in case of deep puncture wounds, animal bites or serious burns the present

• bisters
• thickening of the skin
• while and leathery appearance.

STOP USE

Stop use and ask a doctor if condition persists for more than 3 days or worsens or reoccurs.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

PREGNANCY OR BREAST FEEDING

SPL UNCLASSIFIED SECTION

• Soothing Ointment
• Lidocaine Free
• Benzocaine Free
• Protects & Heals

WARNINGS

For external use only. Avoid contact with eyes.

If swallowed, get medical help or contact a Poison Control Center right away.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CALENDULA 
calendula ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0220-9086
Route of Administration	TOPICAL

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 1 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0220-9086-51	1 in 1 BOX	01/29/2016
1		30 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/29/2016

Labeler - Boiron (282560473)

Registrant - Boiron Inc. (014892269)

Establishment
Name	Address	ID/FEI	Business Operations
Boiron		282560473	manufacture(0220-9086)