Hemcalm Ointment

Hemcalm Ointment
SPL v8
SPL
SPL Set ID 8ff1a5fc-93f6-5782-e053-2a95a90a1785
Route
TOPICAL
Published
Effective Date 2020-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hamamelis Virginiana Root Bark/stem Bark (1 [hp_X]) Collinsonia Canadensis Root Horse Chestnut
Inactive Ingredients
Petrolatum Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2020-01-01

Description

Active ingredients** Aesculus hippocastanum 1X HPUS 1.3% Collinsonia canadensis 1X HPUS 1.3% Hamamelis virginiana 1X HPUS 1.3% 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

Uses*

▪ temporarily relieves symptoms of hemorrhoids such as: ▪ burning ▪ itching ▪ swelling ▪ pain

▪ discomfort

▪ helps shrink swollen hemorrhoids

▪ relieves hemorrhoid symptoms following childbirth

Dosage and Administration
  • Adults and children 12 years of age and older: When practical, gently cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. Apply HemCalm Ointment externally to the affected area up to 4 times a day.
  • Children under 12 years of age: Ask a doctor.
Description

Active ingredients** Aesculus hippocastanum 1X HPUS 1.3% Collinsonia canadensis 1X HPUS 1.3% Hamamelis virginiana 1X HPUS 1.3% 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 tube seal is broken

dispose of 1 year after opening

1 oz (30 g)

Hemorrhoid Relief*

Burning Itching Pain Discomfort

*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 a doctor if symptoms persist for more than 7 days or worsen.

Section 50569-3

Ask a doctor before use in case of bleeding.

Section 50570-1

Do not put this product into the rectum by using fingers or any mechanical device or applicator.

Section 51727-6

alcohol, purified water, white petrolatum USP

Section 51945-4

Section 53413-1

BoironUSA.com [email protected]

1-800-BOIRON-1

(1-800-264-7661)

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*

Aesculus hippocastanum 1X HPUS 1.3% ... Reduces swelling and relieves stinging pain associated with external hemorrhoids

Collinsonia canadensis 1X HPUS 1.3% ... Relieves hemorrhoids associated with constipation

Hamamelis virginiana 1X HPUS 1.3% … Relieves burning, itching, and discomfort associated with hemorrhoids

Section 55106-9

Active ingredients**

Aesculus hippocastanum 1X HPUS 1.3%

Collinsonia canadensis 1X HPUS 1.3%

Hamamelis virginiana 1X HPUS 1.3%

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*

▪ temporarily relieves symptoms of hemorrhoids such as: ▪ burning ▪ itching ▪ swelling ▪ pain

▪ discomfort

▪ helps shrink swollen hemorrhoids

▪ relieves hemorrhoid symptoms following childbirth

Dosage and Administration (34068-7)
  • Adults and children 12 years of age and older: When practical, gently cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. Apply HemCalm Ointment externally to the affected area up to 4 times a day.
  • Children under 12 years of age: Ask a doctor.
Warnings and Precautions (34071-1)

For external use only.

Section 42229-5 (42229-5)

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

dispose of 1 year after opening

1 oz (30 g)

Hemorrhoid Relief*

Burning Itching Pain Discomfort

*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 a doctor if symptoms persist for more than 7 days or worsen.

Section 50569-3 (50569-3)

Ask a doctor before use in case of bleeding.

Section 50570-1 (50570-1)

Do not put this product into the rectum by using fingers or any mechanical device or applicator.

Section 51727-6 (51727-6)

alcohol, purified water, white petrolatum USP

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

BoironUSA.com [email protected]

1-800-BOIRON-1

(1-800-264-7661)

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*

Aesculus hippocastanum 1X HPUS 1.3% ... Reduces swelling and relieves stinging pain associated with external hemorrhoids

Collinsonia canadensis 1X HPUS 1.3% ... Relieves hemorrhoids associated with constipation

Hamamelis virginiana 1X HPUS 1.3% … Relieves burning, itching, and discomfort associated with hemorrhoids

Section 55106-9 (55106-9)

Active ingredients**

Aesculus hippocastanum 1X HPUS 1.3%

Collinsonia canadensis 1X HPUS 1.3%

Hamamelis virginiana 1X HPUS 1.3%

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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