Calendula Ointment

Calendula Ointment
SPL v6
SPL
SPL Set ID 7cd204b9-6716-40ca-96d4-40758fb1ce1f
Route
TOPICAL
Published
Effective Date 2020-09-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Calendula Officinalis Flowering Top (1 [hp_X])
Inactive Ingredients
Water Alcohol Petrolatum

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 1988-07-17
Description

Calendula officinalis 1X HPUS 4% The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Medication Information

Warnings and Precautions

For external use only

Indications and Usage

helps promote healing of: cuts, scrapes, minor burns, temporarily protects and helps relieve chafed, chapped, or cracked skin and lips, helps protect from the drying effects of wind and cold weather

Dosage and Administration

For minor burns, immediately run cool water on the burn for several minutes and pat dry. Then apply a thin layer of Calendula Ointment to affected area 3 times a day or as needed.

For cuts, scrapes, and chapped skin, first cleanse the area with mild soap, rinse and dry. Then apply a thin layer of Calendula Ointment to affected area 3 times a day or as needed.

Dosage Forms and Strengths

Tube 1 OZ (30 G)

Description

Calendula officinalis 1X HPUS 4% The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Section 34073-7

Keep wounds moisturized - Paraben-free - Works naturally with your body

Section 42229-5

†Homeopathic mother tincture made from Calendula officinalis flowering tops.

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

*C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.

Soothes & Heals

Protects Skin

Plant-Based Relief

First Aid*

Cuts, Scrapes, Minor Burns, Chapped Skin*

Section 44425-7

Store at 68-77 O F (20-25 O C)



Section 50565-1

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

Section 50566-9

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

Section 50567-7

When using this product do not get into eyes

Section 50569-3

Consult a doctor in case of deep or puncture wounds, animal bites or serious burns.

Section 50570-1

Do not use if glued carton end flaps are open or if the tube seal is broken.

Do not use if you are allergic to Calendula officinalis or to any of this product's inactive ingredients

Section 51727-6

alcohol, purified water, white petrolatum USP

Section 51945-4

Section 53413-1

Questions, Comments?

BoironCalendula.com

BoironUSA.com

[email protected]

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







Distributed by Boiron Inc.

Newtown Square, PA 19073-3267

Section 53414-9



Section 55105-1

Calendual officianlis 1X HPUS 4% .... Healing agent

Section 55106-9

Calendula officinalis 1X HPUS 4%

The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Structured Label Content

Indications and Usage (34067-9)

helps promote healing of: cuts, scrapes, minor burns, temporarily protects and helps relieve chafed, chapped, or cracked skin and lips, helps protect from the drying effects of wind and cold weather

Dosage and Administration (34068-7)

For minor burns, immediately run cool water on the burn for several minutes and pat dry. Then apply a thin layer of Calendula Ointment to affected area 3 times a day or as needed.

For cuts, scrapes, and chapped skin, first cleanse the area with mild soap, rinse and dry. Then apply a thin layer of Calendula Ointment to affected area 3 times a day or as needed.

Dosage Forms and Strengths (34069-5)

Tube 1 OZ (30 G)

Warnings and Precautions (34071-1)

For external use only

Section 34073-7 (34073-7)

Keep wounds moisturized - Paraben-free - Works naturally with your body

Section 42229-5 (42229-5)

†Homeopathic mother tincture made from Calendula officinalis flowering tops.

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

*C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.

Soothes & Heals

Protects Skin

Plant-Based Relief

First Aid*

Cuts, Scrapes, Minor Burns, Chapped Skin*

Section 44425-7 (44425-7)

Store at 68-77 O F (20-25 O C)



Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

When using this product do not get into eyes

Section 50569-3 (50569-3)

Consult a doctor in case of deep or puncture wounds, animal bites or serious burns.

Section 50570-1 (50570-1)

Do not use if glued carton end flaps are open or if the tube seal is broken.

Do not use if you are allergic to Calendula officinalis or to any of this product's inactive ingredients

Section 51727-6 (51727-6)

alcohol, purified water, white petrolatum USP

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions, Comments?

BoironCalendula.com

BoironUSA.com

[email protected]

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







Distributed by Boiron Inc.

Newtown Square, PA 19073-3267

Section 53414-9 (53414-9)



Section 55105-1 (55105-1)

Calendual officianlis 1X HPUS 4% .... Healing agent

Section 55106-9 (55106-9)

Calendula officinalis 1X HPUS 4%

The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

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Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:10:59.263185 · Updated: 2026-03-14T23:16:02.199714