Rosacea Symptom Relief
FDA Label NDC 57955-0919

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by King Bio Inc. for the product Rosacea Symptom Relief (NDC 57955-0919). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, other safety information, inactive ingredient, otc - purpose, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

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.

Indications & 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.

Warnings

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 breast area.
  • Keep out of reach of children.
  • If swallowed, get medical help or contact a Poison Control Center immediately.

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children.

Dosage & 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.

Other Safety Information

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.

Inactive Ingredient

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.

Otc - Purpose

__________________________________________________________________________________________________________

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

* Please review the disclaimer below.