Cicatrisan Cream

Cicatrisan Cream
SPL v4
SPL
SPL Set ID 156ec27b-d27e-1739-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2015-05-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Balsam Peru (1 [hp_X]) Bryonia Dioica Root Solanum Dulcamara Top Calendula Officinalis Flowering Top Phytolacca Americana Root
Inactive Ingredients
Boric Acid Paraffin Mineral Oil Sorbitan Sesquioleate

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2015-05-07

Description

Active ingredients This preparation contains: Balsamum peruvianum (Peruvian balsam) Balsam MT 1.0% Bryonia dioica (Red bryony) Root MT 1.0% Calendula officinalis (Marigold) Aerial Parts MT 1.0% Dulcamara (Bittersweet) Shoots MT 1.0% Phytolacca decandra (Pokeweed) Root MT 1.0%


Medication Information

Warnings and Precautions

Warnings

For external use only.

Stop use and ask a doctor if symptoms

persist or worsen.

If pregnant or breastfeeding, ask a

health professional before use. Keep out

of reach of children. If swallowed, get

medical help or contact a Poison Control

Center right away.

Indications and Usage

Uses

For the temporary relief of symptoms

associated with minor skin irritations.

Directions

Adults: Apply a small amount on the

affected area two to three times daily, or as

recommended by your healthcare

practitioner. May cover affected area with

sterile gauze after each application.

Children: Use under the direction of your

healthcare practitioner.

Dosage and Administration

Directions

Adults: Apply a small amount on the

affected area two to three times daily, or as

recommended by your healthcare

practitioner. May cover affected area with

sterile gauze after each application.

Children: Use under the direction of your

healthcare practitioner.

Description

Active ingredients This preparation contains: Balsamum peruvianum (Peruvian balsam) Balsam MT 1.0% Bryonia dioica (Red bryony) Root MT 1.0% Calendula officinalis (Marigold) Aerial Parts MT 1.0% Dulcamara (Bittersweet) Shoots MT 1.0% Phytolacca decandra (Pokeweed) Root MT 1.0%

Section 34088-5

If swallowed, get medical help or contact a Poison

Control Center right away.

Section 50565-1

Keep out of reach of children.

Section 51727-6

Inactive ingredients

Boric acid, mineral oil, sorbitan

sesquioleate, white petrolatum

Section 51945-4

NDC 62106-3152-0

UNDA topicals

CICATRISAN CREAM

Homeopathic Preparation

For the temporary relief of symptoms

associated with minor skin irritations.

Net Weight 1.4 oz. (40 g)

Section 55105-1

Uses

For the temporary relief of symptoms

associated with minor skin irritations.

Section 55106-9

Active ingredients

This preparation contains:

Balsamum peruvianum

(Peruvian balsam) Balsam MT 1.0%

Bryonia dioica (Red bryony)

Root MT 1.0%

Calendula officinalis

(Marigold) Aerial Parts MT 1.0%

Dulcamara (Bittersweet)

Shoots MT 1.0%

Phytolacca decandra

(Pokeweed) Root MT 1.0%

Section 60561-8

Other information

Do not use if inner seal is missing or

broken.

Store in a cool, dry place.

Contents may not fill package in order to

accommodate required labeling. Please

rely on stated quantity


Structured Label Content

Indications and Usage (34067-9)

Uses

For the temporary relief of symptoms

associated with minor skin irritations.

Directions

Adults: Apply a small amount on the

affected area two to three times daily, or as

recommended by your healthcare

practitioner. May cover affected area with

sterile gauze after each application.

Children: Use under the direction of your

healthcare practitioner.

Dosage and Administration (34068-7)

Directions

Adults: Apply a small amount on the

affected area two to three times daily, or as

recommended by your healthcare

practitioner. May cover affected area with

sterile gauze after each application.

Children: Use under the direction of your

healthcare practitioner.

Warnings and Precautions (34071-1)

Warnings

For external use only.

Stop use and ask a doctor if symptoms

persist or worsen.

If pregnant or breastfeeding, ask a

health professional before use. Keep out

of reach of children. If swallowed, get

medical help or contact a Poison Control

Center right away.

Section 34088-5 (34088-5)

If swallowed, get medical help or contact a Poison

Control Center right away.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

Inactive ingredients

Boric acid, mineral oil, sorbitan

sesquioleate, white petrolatum

Section 51945-4 (51945-4)

NDC 62106-3152-0

UNDA topicals

CICATRISAN CREAM

Homeopathic Preparation

For the temporary relief of symptoms

associated with minor skin irritations.

Net Weight 1.4 oz. (40 g)

Section 55105-1 (55105-1)

Uses

For the temporary relief of symptoms

associated with minor skin irritations.

Section 55106-9 (55106-9)

Active ingredients

This preparation contains:

Balsamum peruvianum

(Peruvian balsam) Balsam MT 1.0%

Bryonia dioica (Red bryony)

Root MT 1.0%

Calendula officinalis

(Marigold) Aerial Parts MT 1.0%

Dulcamara (Bittersweet)

Shoots MT 1.0%

Phytolacca decandra

(Pokeweed) Root MT 1.0%

Section 60561-8 (60561-8)

Other information

Do not use if inner seal is missing or

broken.

Store in a cool, dry place.

Contents may not fill package in order to

accommodate required labeling. Please

rely on stated quantity


Advanced Ingredient Data


Raw Label Data

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