Tinni-Calm

Manufacturer
Silver Star Brands | Vitality Works
Effective date
2020-12-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:13:57

Label at a glance#

ProductTinni-Calm
Active ingredientCARBON DISULFIDE, SILICON DIOXIDE, HYDROQUININE SULFATE, MAGNESIUM SALICYLATE, MATRICARIA CHAMOMILLA FLOWERING TOP OIL
Label structure11 sections

Indications and uses

Uses†: For symptomatic treatment of ringing, buzzing, undesirable noises, and general discomfort in the ears. † as per various homeopathic materia medicas. These uses have not been evaluated by the FD, and product has not been clinically tested.

Dosage and administration

Directions: Shake well before using. Use at firest sign of symptoms. Dispense a small amount into hands. Massage gently onto cartilage of ourter ear canal and outer nostrils. Inhale deeply and slowly maintaining stillness. Repeat as needed. FOR EXTERNAL USE ONLY

Label contents#

Full prescribing information#

HPUS Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

HPUS Active Ingredients: Each does contains equal volumes of: Carboneum sulphuratum, Chamomilla, Chininum sulphuricum, Salicylicum acidicum, Silicea.

Uses†

INDICATIONS & USAGE SECTION

Uses†: For symptomatic treatment of ringing, buzzing, undesirable noises, and general discomfort in the ears.

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

Warngings

WARNINGS SECTION

Warnings: For external use only. If symptoms persist or worsen, discontinue use immediately and consutle a healthcare professional. If pregnant or breastfeeding, as ka health professional before use. Keep this and all medication out of reach of children. Avoid using near eyes or mouth. If swallowed, get medical help or contact a Poison Control Center immediately.

Discontinue sue if irritation or reaction occurs.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions: Shake well before using. Use at firest sign of symptoms. Dispense a small amount into hands. Massage gently onto cartilage of ourter ear canal and outer nostrils. Inhale deeply and slowly maintaining stillness. Repeat as needed.

FOR EXTERNAL USE ONLY

OTHER SAFETY INFORMATION

Keep carton for additional drug facts and information.

Tamper resistant for your protection.

Use only if safety seal is intact.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Grapeseed oil, ginger essential oil, cypress essential oil, grapefruit essential oil, lemon essential oil.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medication out of reach of children.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a health professional before use.

OTC - PURPOSE SECTION

Temporarily soothes symptoms associated with ringing in the ears.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tinni-Calm LabelTinni-Calm Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tinni-Calm CartonTinni-Calm Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68703-212-302022-01-28C16284748780-1d6a99b39-4cbd-a426-e053-dadaa90af4c2Healthful™ Naturals Tinni-Calm

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68703-212-30Tinni-Calm30 mL in 1 BOTTLE, GLASSOIL301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68703-212TINNI-CALM (CARBONEUM, SULPHURATUM, CHAMOMILLA, CHININUM, SULPHURICUM, SALICYLICUM ACIDUM, SILICEA) OIL [SILVER STAR BRANDS]1Legacy NDC, 1 package rows20201212_b6212e7e-b4e3-0044-e053-2995a90ac2ca.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68703-21268703-212-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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
b6212e7e-b4e4-0044-e053-2995a90ac2cab6212e7e-b4e3-0044-e053-2995a90ac2ca2020-12-10WarningsExact identifier
spl id: b6212e7e-b4e4-0044-e053-2995a90ac2ca
spl set id: b6212e7e-b4e3-0044-e053-2995a90ac2ca