SPL v8
SPL
SPL Set ID b8ba495e-2cfe-092c-e053-2995a90a3fd3
Routes
DENTAL TOPICAL SUBLINGUAL
Published
Effective Date 2021-01-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ledum Palustre Twig (6 [hp_X]) Calendula Officinalis Flowering Top (3 [hp_X]) Echinacea Angustifolia (10 [hp_X]) Hypericum Perforatum (30 [hp_X]) Strychnos Ignatii Seed (8 [hp_X]) Silicon Dioxide (12 [hp_X]) Ruta Graveolens Flowering Top (18 [hp_X]) Arnica Montana (5 [hp_X]) Matricaria Recutita (1 [hp_X]) Echinacea Purpurea Delphinium Staphisagria Seed Calcium Sulfide Azadirachta Indica Bark Calendula Officinalis Flower Plantago Major
Inactive Ingredients
Peppermint Oil Hydroxyethyl Cellulose (100 Mpa.s At 2%) Water Sodium Benzoate Xylitol Allantoin Citric Acid Monohydrate Potassium Sorbate Glycerin Propolis Wax Polysorbate 20 Mentha Piperita Leaf

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2021-01-08

Description

Temporarily Relieves pain and swelling. Promotes healing. Reduces bruising.


Medication Information

Description

Temporarily Relieves pain and swelling. Promotes healing. Reduces bruising.

Uses

Temporarily

  • Relieves pain and swelling.
  • Promotes healing.
  • Reduces bruising.
Usage

Temporarily

  • Relieves pain and swelling.
  • Promotes healing.
  • Reduces bruising.
Warnings

Do not use if you have a known allergy or sensitivity to any of the following ingredients

Stop use and consult a healthcare professional if you experience irritation or unusual sensitivity, or develop a rash.

As with any drug, if you are pregnant or nursing a baby, seek the advice of a healthcare professional before using this product.

Keep this and all drugs out of the reach of children. In case of accidental overdose, seek professional assistance or contact poison control center immediately.

If pain, swelling or other related symptoms persist for more than 7 days of use, contact a dental professional.

Directions

Adults and children over 6 years of age: Shake well. Spray 4 times per application under the tongue. Repeat 3-4 times per day or as directed by your doctor. Consult a healthcare professional for use in children under 6 years of age.

Drug Facts

Contains 7.14% of each of the following HPUS ingredients:

Active Ingredients Purpose

Arnica 3X, 6X, 18X

Bruising, swelling

Calendula 3X Antiseptic
Chamomilla 5X Swelling

Echinacea angustifolia 3X

Antiseptic
Echinacea purpurea 3X Antiseptic

Hepar sulph calc 8X

Antiseptic

Hypericum 10X

Bruising, would healing

Ignata 30X

Soothing

Ledum palustre 6X

Analgesic

Ruta 12X

Bruising

Silicea 8X

Analgesic, antiseptic

Staphysagria 8X

Analgesic, soothing

Other Information

For your protection, this bottle has a full body seal. Do not use if this tamper evident seal is broken or missing.

Store at room temperature.

Keep away from direct heat or sunlight.

Because of natural ingredients, color may vary over time.

Use within 60 days of opening.

Inactive Ingredients

Citric acid, Glycerin, Potassium sorbate, Purified water.

Keep Out of Reach of Children

Keep this and all drugs out of reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately.

Stellalife Vega Oral Care Spray

Stellalife Vega Oral Care Gel Display

Stellalife Vega Oral Care Spray Display

Stellalife Vega Oral Care Recovery Kit Display


Structured Label Content

Uses

Temporarily

  • Relieves pain and swelling.
  • Promotes healing.
  • Reduces bruising.
Usage

Temporarily

  • Relieves pain and swelling.
  • Promotes healing.
  • Reduces bruising.
Warnings

Do not use if you have a known allergy or sensitivity to any of the following ingredients

Stop use and consult a healthcare professional if you experience irritation or unusual sensitivity, or develop a rash.

As with any drug, if you are pregnant or nursing a baby, seek the advice of a healthcare professional before using this product.

Keep this and all drugs out of the reach of children. In case of accidental overdose, seek professional assistance or contact poison control center immediately.

If pain, swelling or other related symptoms persist for more than 7 days of use, contact a dental professional.

Directions

Adults and children over 6 years of age: Shake well. Spray 4 times per application under the tongue. Repeat 3-4 times per day or as directed by your doctor. Consult a healthcare professional for use in children under 6 years of age.

Drug Facts

Contains 7.14% of each of the following HPUS ingredients:

Active Ingredients Purpose

Arnica 3X, 6X, 18X

Bruising, swelling

Calendula 3X Antiseptic
Chamomilla 5X Swelling

Echinacea angustifolia 3X

Antiseptic
Echinacea purpurea 3X Antiseptic

Hepar sulph calc 8X

Antiseptic

Hypericum 10X

Bruising, would healing

Ignata 30X

Soothing

Ledum palustre 6X

Analgesic

Ruta 12X

Bruising

Silicea 8X

Analgesic, antiseptic

Staphysagria 8X

Analgesic, soothing

Other Information

For your protection, this bottle has a full body seal. Do not use if this tamper evident seal is broken or missing.

Store at room temperature.

Keep away from direct heat or sunlight.

Because of natural ingredients, color may vary over time.

Use within 60 days of opening.

Inactive Ingredients

Citric acid, Glycerin, Potassium sorbate, Purified water.

Keep Out of Reach of Children

Keep this and all drugs out of reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately.

Stellalife Vega Oral Care Spray (StellaLife VEGA Oral Care Spray)

Stellalife Vega Oral Care Gel Display (StellaLife VEGA Oral Care Gel Display)

Stellalife Vega Oral Care Spray Display (StellaLife VEGA Oral Care Spray Display)

Stellalife Vega Oral Care Recovery Kit Display (StellaLife VEGA Oral Care Recovery Kit Display)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)