Hpus Active Ingredients
HPUS Active Ingredients: Each does contains equal volumes of: Carboneum sulphuratum, Chamomilla, Chininum sulphuricum, Salicylicum acidicum, Silicea.
Tinni-calm
FDA Label NDC 68703-212
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Silver Star Brands for the product Tinni-calm (NDC 68703-212). 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 hpus active ingredients, uses†, warngings, directions, other safety information, inactive ingredients, otc - keep out of reach of children, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
Warngings
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
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 Ingredients: Grapeseed oil, ginger essential oil, cypress essential oil, grapefruit essential oil, lemon essential oil.
Otc - Keep Out Of Reach Of Children
Keep this and all medication out of reach of children.
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding, ask a health professional before use.
Otc - Purpose
Temporarily soothes symptoms associated with ringing in the ears.
Package Label.Principal Display Panel
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