Rosacea Symptom Relief

Rosacea Symptom Relief
SPL v3
SPL
SPL Set ID a6569a43-a207-4a5f-b059-8964f5732ae1
Route
TOPICAL
Published
Effective Date 2017-01-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Calendula Officinalis Flowering Top (10 [hp_X]) Cardiospermum Halicacabum Flowering Top (2 [hp_X]) Matricaria Recutita (3 [hp_X]) Centella Asiatica Toxicodendron Pubescens Leaf Thuja Occidentalis Leafy Twig
Inactive Ingredients
Aloe Vera Leaf Oatmeal Carrageenan Chamomile Citrus Bioflavonoids Glycerin Green Tea Leaf Lonicera Japonica Flower Lecithin, Soybean Licorice Azadirachta Indica Seed Oil Mahonia Aquifolium Root Alcohol Rice Bran Water Silicon Dioxide Sucrose Cocoate Sunflower Oil Xanthan Gum

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2017-03-01

Description

Drug Facts_ _________________________________________________________________________________________________________ HPUS active ingredient                                                                  Purpose†  Equal volumes of each active ingredient in 10X, 20X, and 30X potencies, unless otherwise noted. Active ingredients 50% of total weight. Calendula officinalis, Cardiospermum (2X, 10X, 20X, 30X), Chamomilla, Hydrocotyle asiatica, Rhus tox, Thuja occidentalis (3X, 10X, 20X, 30X). *"HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.


Medication Information

Warnings and Precautions

Warnings

  • For external use only. Avoid contact with eyes.
  • Stop use and ask a doctor if •increased skin irritation, pimples, redness or other allergic reaction develops. •symptoms worsen or do not improve within 7 days.
  • Nursing mothers should not apply to bre ast area.
  • Keep out of reach of children.
  • If swallowed, get medical help or contact a Poison Control Center immediately.
Indications and Usage

Uses for temporary relief of multiple symptoms of rosacea: •facial redness •burning •stinging •allergic skin eruptions •itching •dermatitis •pimples •swelling •thickening of skin.

† as per various homeopathic materia medicas. These uses have not been evaluated by the FDA, and product has not been clinically tested.

Dosage and Administration

Directions

•Shake before using. •Adults & children 2 years of age and older: apply to affected area up to 4 times daily. Rub in gently. •Children under 2 years of age: consult a doctor. •Patch test recommended on sensitive skin.

Description

Drug Facts_ _________________________________________________________________________________________________________ HPUS active ingredient                                                                  Purpose†  Equal volumes of each active ingredient in 10X, 20X, and 30X potencies, unless otherwise noted. Active ingredients 50% of total weight. Calendula officinalis, Cardiospermum (2X, 10X, 20X, 30X), Chamomilla, Hydrocotyle asiatica, Rhus tox, Thuja occidentalis (3X, 10X, 20X, 30X). *"HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.

Section 50565-1
  • Keep out of reach of children.
Section 51727-6

Inactive ingredients:​ Aloe vera leaf juice powder*, avena sativa oat kernel flour*, carrageenan, chamomile​ recutita flower extract*, citrus extract*, glycerin, green tea extract*, honeysuckle extract*, lecithin*, licorice root extract*, neem seed oil*, oregon grape root extract*, organic alcohol*, oryza sativa race bran extract*, silicon dioxide, sucrose cocoate, sunflower oil*, water, xanthan gum.

*Certified Organic Ingredient.

Certified Organic by Oregon Tilth.

Section 51945-4

Section 55105-1

__________________________________________________________________________________________________________

HPUS active ingredient                                                              Purpose†

Equal volumes of each active ingredient in 10X, 20X, and 30X potencies, unless otherwise noted.

Active ingredients 50% of total weight. 

Calendula officinalis........................................................................burning, stinging, puffy face

Cardiospermum (2X, 10X, 20X, 30X)......................................flush of heat, allergic skin eruptions

Chamomilla....................................................................................................red and hot skin

Hydrocotyle asiatica.....................................................rosacea, skin disorders, thickening of skin

Rhus tox...................................................swelling, redness, pimples, itching, dermatitis, rosacea

Thuja occidentalis (3X, 10X, 20X, 30X).............long-term skin troubles, sensitive skin, burning heat

and facial redness

Section 55106-9

Drug Facts__________________________________________________________________________________________________________

HPUS active ingredient                                                                  Purpose† 

Equal volumes of each active ingredient in 10X, 20X, and 30X potencies, unless otherwise noted.

Active ingredients 50% of total weight.

Calendula officinalis, Cardiospermum (2X, 10X, 20X, 30X), Chamomilla, Hydrocotyle asiatica, Rhus tox, Thuja occidentalis (3X, 10X, 20X, 30X).

*"HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.

Section 60561-8

Other information:

  • To open: unscrew cap, remove tube seal, replace cap.
  • Safety sealed for your protection.
  • Do not use if tube seal is missing.
  • Store at 68-77° (20-25°C).
  • Certified organic topical lotion.

Structured Label Content

Indications and Usage (34067-9)

Uses for temporary relief of multiple symptoms of rosacea: •facial redness •burning •stinging •allergic skin eruptions •itching •dermatitis •pimples •swelling •thickening of skin.

† as per various homeopathic materia medicas. These uses have not been evaluated by the FDA, and product has not been clinically tested.

Dosage and Administration (34068-7)

Directions

•Shake before using. •Adults & children 2 years of age and older: apply to affected area up to 4 times daily. Rub in gently. •Children under 2 years of age: consult a doctor. •Patch test recommended on sensitive skin.

Warnings and Precautions (34071-1)

Warnings

  • For external use only. Avoid contact with eyes.
  • Stop use and ask a doctor if •increased skin irritation, pimples, redness or other allergic reaction develops. •symptoms worsen or do not improve within 7 days.
  • Nursing mothers should not apply to bre ast area.
  • Keep out of reach of children.
  • If swallowed, get medical help or contact a Poison Control Center immediately.
Section 50565-1 (50565-1)
  • Keep out of reach of children.
Section 51727-6 (51727-6)

Inactive ingredients:​ Aloe vera leaf juice powder*, avena sativa oat kernel flour*, carrageenan, chamomile​ recutita flower extract*, citrus extract*, glycerin, green tea extract*, honeysuckle extract*, lecithin*, licorice root extract*, neem seed oil*, oregon grape root extract*, organic alcohol*, oryza sativa race bran extract*, silicon dioxide, sucrose cocoate, sunflower oil*, water, xanthan gum.

*Certified Organic Ingredient.

Certified Organic by Oregon Tilth.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

__________________________________________________________________________________________________________

HPUS active ingredient                                                              Purpose†

Equal volumes of each active ingredient in 10X, 20X, and 30X potencies, unless otherwise noted.

Active ingredients 50% of total weight. 

Calendula officinalis........................................................................burning, stinging, puffy face

Cardiospermum (2X, 10X, 20X, 30X)......................................flush of heat, allergic skin eruptions

Chamomilla....................................................................................................red and hot skin

Hydrocotyle asiatica.....................................................rosacea, skin disorders, thickening of skin

Rhus tox...................................................swelling, redness, pimples, itching, dermatitis, rosacea

Thuja occidentalis (3X, 10X, 20X, 30X).............long-term skin troubles, sensitive skin, burning heat

and facial redness

Section 55106-9 (55106-9)

Drug Facts__________________________________________________________________________________________________________

HPUS active ingredient                                                                  Purpose† 

Equal volumes of each active ingredient in 10X, 20X, and 30X potencies, unless otherwise noted.

Active ingredients 50% of total weight.

Calendula officinalis, Cardiospermum (2X, 10X, 20X, 30X), Chamomilla, Hydrocotyle asiatica, Rhus tox, Thuja occidentalis (3X, 10X, 20X, 30X).

*"HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.

Section 60561-8 (60561-8)

Other information:

  • To open: unscrew cap, remove tube seal, replace cap.
  • Safety sealed for your protection.
  • Do not use if tube seal is missing.
  • Store at 68-77° (20-25°C).
  • Certified organic topical lotion.

Advanced Ingredient Data


Raw Label Data

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