Calendula Gel 1.5oz

Calendula Gel 1.5oz
SPL v6
SPL
SPL Set ID b775b879-6037-44a3-a5bd-045f2d923f3b
Route
TOPICAL
Published
Effective Date 2019-08-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Calendula Officinalis Flowering Top (1 [hp_X])
Inactive Ingredients
Alcohol Caprylyl Glycol Carbomer Homopolymer Type C Water Sodium Hydroxide Sorbic Acid 1,2-hexanediol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 1993-09-30

Description

Active ingredients** Calendula officinalis 1X HPUS 7% 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.

Indications and Usage

Uses*

helps promote healing of skin irritations such as:

  • rashes
  • razor burns
  • insect bites or stings
Dosage and Administration
  • First cleanse the area with mild soap, rinse and dry.
  • Then apply a thin layer of Calendula Gel to affected area 3 times a day or as needed.
Description

Active ingredients** Calendula officinalis 1X HPUS 7% 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 glued carton end flaps are open or if the tube seal is broken

store at 68-77 o F (20-25 o C)

Skin Irritations*

Rashes Razor Burn Insect Bites*

For all ages

1.5 oz (45 g)

*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 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 this product's inactive ingredients.

Section 51727-6

alcohol, caprylyl glycol, carbomer, purified water, sodium hydroxide, sorbic acid, 1,2-hexanediol

Section 51945-4

Section 53413-1

BoironCalendula.com

BoironUSA.com

[email protected]

1-800-BOIRON-1

1-800-264-7661)



Distributed by Boiron, Inc.

Newtown Square, PA 19073

Made in France

Section 55105-1

Purpose*

Calendula officinalis 1X HPUS 7% ... Healing agent

Section 55106-9

Active ingredients**

Calendula officinalis 1X HPUS 7%

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)

Uses*

helps promote healing of skin irritations such as:

  • rashes
  • razor burns
  • insect bites or stings
Dosage and Administration (34068-7)
  • First cleanse the area with mild soap, rinse and dry.
  • Then apply a thin layer of Calendula Gel to affected area 3 times a day or as needed.
Warnings and Precautions (34071-1)

For external use only. Avoid contact with eyes.

Section 42229-5 (42229-5)

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

store at 68-77 o F (20-25 o C)

Skin Irritations*

Rashes Razor Burn Insect Bites*

For all ages

1.5 oz (45 g)

*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 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 this product's inactive ingredients.

Section 51727-6 (51727-6)

alcohol, caprylyl glycol, carbomer, purified water, sodium hydroxide, sorbic acid, 1,2-hexanediol

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

BoironCalendula.com

BoironUSA.com

[email protected]

1-800-BOIRON-1

1-800-264-7661)



Distributed by Boiron, Inc.

Newtown Square, PA 19073

Made in France

Section 55105-1 (55105-1)

Purpose*

Calendula officinalis 1X HPUS 7% ... Healing agent

Section 55106-9 (55106-9)

Active ingredients**

Calendula officinalis 1X HPUS 7%

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

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