Calendula Cream 2.5oz, 0.5oz, 0.18oz

Calendula Cream 2.5oz, 0.5oz, 0.18oz
SPL v12
SPL
SPL Set ID 2ed51803-5ec2-4163-ad12-2bf441551f07
Route
TOPICAL
Published
Effective Date 2025-12-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Calendula Officinalis Flowering Top (1 [hp_X])
Inactive Ingredients
Arachidyl Alcohol Xanthan Gum Butyrospermum Parkii (shea) Butter Unsaponifiables Glycerin Water Docosanol Arachidyl Glucoside Coconut Oil Limosilactobacillus Fermentum

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2006-03-21

Description

Active ingredient** Calendula officinalis 1X HPUS 10% 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 minor:
  • cuts
  • scrapes
  • chafing
  • burns
  • sunburn
  • protects skin
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 Cream to affected area 3 times a day.

For cuts, scrapes, chafed skin, and sunburn, first cleanse the area with mild soap, rinse, and pat dry. Then apply a thin layer of Calendula Cream to affected area 3 times a day.

Description

Active ingredient** Calendula officinalis 1X HPUS 10% The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Section 42229-5

do not use if pouch is torn or open

dispose of 1 day after opening (0.18 oz / 5g)

do not use if glued carton end flaps are open

dispose of 1 day after opening (2.6 OZ / 70 G)

Pouch 0.18 OZ (5g)

Tube 2.6 OZ (70 G)

Tube 0.5 OZ (14 G)

FIRST AID*

Cuts Scrapes Minor Burns Sunburn*

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 50565-1

Keep out of reach of children. If swallowed, 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
  • avoid diaper area
Section 50569-3

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

Section 50570-1

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

Section 51727-6

arachidyl alcohol, arachidyl glucoside, behenyl alcohol, Butyrospermum parkii (Shea) butter, coconut oil, glycerin, lactobacillus ferment, purified water, xanthan gum

Section 51945-4

Section 53413-1

Questions, Comments?

BoironCalendula.com BoironUSA.com

[email protected]

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





Made in France

Distributed by Boiron, Inc.

Newtown Square, PA 19073

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Purpose*

Calendula officinalis 1X HPUS 10% ... Healing agent

Section 55106-9

Active ingredient**

Calendula officinalis 1X HPUS 10%

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 minor:
  • cuts
  • scrapes
  • chafing
  • burns
  • sunburn
  • protects skin
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 Cream to affected area 3 times a day.

For cuts, scrapes, chafed skin, and sunburn, first cleanse the area with mild soap, rinse, and pat dry. Then apply a thin layer of Calendula Cream to affected area 3 times a day.

Warnings and Precautions (34071-1)

For external use only.

Section 42229-5 (42229-5)

do not use if pouch is torn or open

dispose of 1 day after opening (0.18 oz / 5g)

do not use if glued carton end flaps are open

dispose of 1 day after opening (2.6 OZ / 70 G)

Pouch 0.18 OZ (5g)

Tube 2.6 OZ (70 G)

Tube 0.5 OZ (14 G)

FIRST AID*

Cuts Scrapes Minor Burns Sunburn*

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 50565-1 (50565-1)

Keep out of reach of children. If swallowed, 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
  • avoid diaper area
Section 50569-3 (50569-3)

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

Section 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

arachidyl alcohol, arachidyl glucoside, behenyl alcohol, Butyrospermum parkii (Shea) butter, coconut oil, glycerin, lactobacillus ferment, purified water, xanthan gum

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)





Made in France

Distributed by Boiron, Inc.

Newtown Square, PA 19073

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purpose*

Calendula officinalis 1X HPUS 10% ... Healing agent

Section 55106-9 (55106-9)

Active ingredient**

Calendula officinalis 1X HPUS 10%

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)