Rosacea Symptom Relief

Manufacturer
King Bio Inc.
Effective date
2017-01-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:08:36

Label at a glance#

ProductRosacea Symptom Relief
Active ingredientCALENDULA OFFICINALIS FLOWERING TOP, CARDIOSPERMUM HALICACABUM FLOWERING TOP, MATRICARIA RECUTITA, CENTELLA ASIATICA, TOXICODENDRON PUBESCENS LEAF, THUJA OCCIDENTALIS LEAFY TWIG
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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 SECTION

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 SECTION

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 SECTION

  • Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

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 SECTION

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 SECTION

__________________________________________________________________________________________________________

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57955-0919-32020-01-31C16284748780-19d75b9d0-f4ab-f424-e053-dadaa90a57ceRosacea Symptom Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57955-0919-3Rosacea Symptom Relief1 in 1 CARTONCREAM13
57955-0919-3Rosacea Symptom Relief85 g in 1 TUBECREAM853

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57955-0919ROSACEA SYMPTOM RELIEF (CALENDULA OFFICINALIS, CARDIOSPERMUM, CHAMOMILLA, HYDROCOTYLE ASIATICA, RHUS TOX, THUJA OCCIDENTALIS) CREAM [KING BIO INC.]3Legacy NDC, 2 package rows20170301_a6569a43-a207-4a5f-b059-8964f5732ae1.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57955-091957955-0919-3

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f566190d-1c29-406e-8c3e-9a3d6cb632e8a6569a43-a207-4a5f-b059-8964f5732ae12017-01-20WarningsExact identifier
spl id: f566190d-1c29-406e-8c3e-9a3d6cb632e8
spl set id: a6569a43-a207-4a5f-b059-8964f5732ae1

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.