Unda Creams

Unda Creams
SPL v11
SPL
SPL Set ID 079c4f1c-836d-1113-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2015-01-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Calendula Officinalis Flowering Top (1 [hp_X]) Arnica Montana
Inactive Ingredients
Glycerin Cetostearyl Alcohol Water Rose Oil

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2015-01-20

Description

Active ingredients Calendula officinalis (Marigold) Aerial Parts MT 5.0%


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 cuts and burns

Directions

Adults: Apply a small amount on the affected area two to three times daily, or as

recommended by your healthcare practitioner.

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.

Children: Use under the direction of your healthcare practitioner.

Description

Active ingredients Calendula officinalis (Marigold) Aerial Parts MT 5.0%

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

Cetostearyl alcohol, glycerin, purified water, rose oil

Section 51945-4

NDC 62106-1177-0

UNDA topicals

CALENDULA CREAM

Homeopathic Preparation

For the temporary relief of symptoms

associated with minor cuts and burns.

Net Weight 1.4 oz (40 g)

Section 55105-1

Uses

For the temporary relief of symptoms associated with minor cuts and burns

Section 55106-9

Active ingredients

Calendula officinalis (Marigold) Aerial Parts MT 5.0%

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 cuts and burns

Directions

Adults: Apply a small amount on the affected area two to three times daily, or as

recommended by your healthcare practitioner.

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.

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

Cetostearyl alcohol, glycerin, purified water, rose oil

Section 51945-4 (51945-4)

NDC 62106-1177-0

UNDA topicals

CALENDULA CREAM

Homeopathic Preparation

For the temporary relief of symptoms

associated with minor cuts and burns.

Net Weight 1.4 oz (40 g)

Section 55105-1 (55105-1)

Uses

For the temporary relief of symptoms associated with minor cuts and burns

Section 55106-9 (55106-9)

Active ingredients

Calendula officinalis (Marigold) Aerial Parts MT 5.0%

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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