TINNI-CALM- carboneum, sulphuratum, chamomilla, chininum, sulphuricum, salicylicum acidum, silicea oil

Tinni-Calm by

Drug Labeling and Warnings

Tinni-Calm by is a Homeopathic medication manufactured, distributed, or labeled by Silver Star Brands, Vitality Works. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HPUS Active Ingredients

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

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.

KEEP OUT OF REACH OF CHILDREN

Keep this and all medication out of reach of children.

PREGNANCY OR BREAST FEEDING

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

PURPOSE

Temporarily soothes symptoms associated with ringing in the ears.

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TINNI-CALM 
carboneum, sulphuratum, chamomilla, chininum, sulphuricum, salicylicum acidum, silicea oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68703-212
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CARBON DISULFIDE (UNII: S54S8B99E8) (CARBON DISULFIDE - UNII:S54S8B99E8)	CARBON DISULFIDE	6 [hp_C]  in 30 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	30 [hp_C]  in 30 mL
HYDROQUININE SULFATE (UNII: F507371PJA) (HYDROQUININE - UNII:31J3Q51T6L)	HYDROQUININE SULFATE	6 [hp_C]  in 30 mL
MAGNESIUM SALICYLATE (UNII: 41728CY7UX) (SALICYLIC ACID - UNII:O414PZ4LPZ)	MAGNESIUM SALICYLATE	6 [hp_C]  in 30 mL
MATRICARIA CHAMOMILLA FLOWERING TOP OIL (UNII: SA8AR2W4ER) (MATRICARIA CHAMOMILLA FLOWERING TOP OIL - UNII:SA8AR2W4ER)	MATRICARIA CHAMOMILLA FLOWERING TOP OIL	6 [hp_C]  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
GRAPEFRUIT (UNII: O82C39RR8C)
LEMON OIL (UNII: I9GRO824LL)
GRAPE SEED OIL (UNII: 930MLC8XGG)
GINGER OIL (UNII: SAS9Z1SVUK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68703-212-30	30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	12/14/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		12/14/2016

Labeler - Silver Star Brands (006070379)

Registrant - Silver Star Brands (006070379)

Establishment
Name	Address	ID/FEI	Business Operations
Vitality Works		137752817	manufacture(68703-212)