Calendula Burn

Calendula Burn
SPL v4
SPL
SPL Set ID 28c76b61-2a0c-0f52-e054-00144ff8d46c
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
Alcohol Petrolatum Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2016-01-29
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. Avoid contact with eyes.

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

Indications and Usage
  • Temporarily protects and helps promote healing of minor burns.

Dosage and 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.

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 42229-5

Soothes & Heals

Protects Skin

Plant-based relief

No fragrances, dyes or parabens

For all ages

Burn Relief*

Minor Burns*

ɨ 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.

Section 44425-7

Store below 68-77° F (20-25° C)

Section 50565-1

Keep out of reach of children

Section 50566-9

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

Section 50569-3





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

  • bisters
  • thickening of the skin
  • white and leathery appearance.
Section 50570-1

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.
Section 51727-6

White petrolatum USP, alcohol, purfied water

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 55105-1

Calendula officinalis 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)
  • Temporarily protects and helps promote healing of minor burns.

Dosage and Administration (34068-7)

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.

Dosage Forms and Strengths (34069-5)

Tube 1 OZ (30 G)

Warnings and Precautions (34071-1)

For external use only. Avoid contact with eyes.

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

Section 42229-5 (42229-5)

Soothes & Heals

Protects Skin

Plant-based relief

No fragrances, dyes or parabens

For all ages

Burn Relief*

Minor Burns*

ɨ 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.

Section 44425-7 (44425-7)

Store below 68-77° F (20-25° C)

Section 50565-1 (50565-1)

Keep out of reach of children

Section 50566-9 (50566-9)

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

Section 50569-3 (50569-3)





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

  • bisters
  • thickening of the skin
  • white and leathery appearance.
Section 50570-1 (50570-1)

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.
Section 51727-6 (51727-6)

White petrolatum USP, alcohol, purfied water

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 55105-1 (55105-1)

Calendula officinalis 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.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:10:59.281637 · Updated: 2026-03-14T23:16:02.199714