Ocumend

Ocumend
SPL v3
SPL
SPL Set ID dfdfb21d-c592-49c2-a66d-55a53f28275f
Route
TOPICAL
Published
Effective Date 2020-06-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arnica Montana (50 [hp_X]) Ledum Palustre Twig
Inactive Ingredients
Hydroxyethyl Cellulose, Unspecified Methyl Diethanolamine Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2020-09-01

Description

      Arnica Montana 50M 50% HPUS       Ledum Palustre 50M 50% HPUS

Purpose

      Arnica Montana 50M HPUS: Bruising       Ledum Palustre 50M HPUS: Black Eye


Medication Information

Purpose

      Arnica Montana 50M HPUS: Bruising       Ledum Palustre 50M HPUS: Black Eye

Description

      Arnica Montana 50M 50% HPUS       Ledum Palustre 50M 50% HPUS

Uses

      For the reduction of bruising, swelling, and pain.

Active

      Arnica Montana 50M 50% HPUS

      Ledum Palustre 50M 50% HPUS

Warnings

For external use only

Directions

      Use as directed by a physician. Place healing gels on intact skin and replace as needed.

Do Not Use

      in the eyes, over open wounds, or if you have unexpected bleeding

Questions?

      Call: 1 (800) 678-1605

Description:

The letters ‘HPUS’ indicate that the component(s) in this product is (are) officially monographed in the Homeopathic Pharmacopeia of the United States. Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

      Do not use if peel pouches are open.

Other Information

      Store at room temperature.

Homeopathic Purpose

      Arnica Montana 50M HPUS: Bruising

      Ledum Palustre 50M HPUS: Black Eye

Inactive Ingredients

Acrylates/Acrylamide Co-polymer, Hydroxyethyl Cellulose, Methyldiethanolamine, Water

Principal Display Panel

OCUMEND®

Healing Gels for the Reduction

of Bruising, Swelling, and Pain

Contents: 13 – Healing Gel Two-Packs

Stop Use and Ask A Doctor If

      condition worsens.

If Pregnant Or Breast Feeding,

      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.


Structured Label Content

Uses (USES)

      For the reduction of bruising, swelling, and pain.

Active (ACTIVE)

      Arnica Montana 50M 50% HPUS

      Ledum Palustre 50M 50% HPUS

Warnings (WARNINGS)

For external use only

Directions (DIRECTIONS)

      Use as directed by a physician. Place healing gels on intact skin and replace as needed.

Do Not Use (Do not use)

      in the eyes, over open wounds, or if you have unexpected bleeding

Questions? (QUESTIONS?)

      Call: 1 (800) 678-1605

Description: (DESCRIPTION:)

The letters ‘HPUS’ indicate that the component(s) in this product is (are) officially monographed in the Homeopathic Pharmacopeia of the United States. Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

      Do not use if peel pouches are open.

Other Information (OTHER INFORMATION)

      Store at room temperature.

Homeopathic Purpose (HOMEOPATHIC PURPOSE)

      Arnica Montana 50M HPUS: Bruising

      Ledum Palustre 50M HPUS: Black Eye

Inactive Ingredients (INACTIVE INGREDIENTS)

Acrylates/Acrylamide Co-polymer, Hydroxyethyl Cellulose, Methyldiethanolamine, Water

Principal Display Panel

OCUMEND®

Healing Gels for the Reduction

of Bruising, Swelling, and Pain

Contents: 13 – Healing Gel Two-Packs

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

      condition worsens.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

      ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

      If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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