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

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Healthful™ Naturals Tinni-Calm

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

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 this and all medication out of reach of children.

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

Temporarily soothes symptoms associated with ringing in the ears.

Tinni-Calm Label

Tinni-Calm Carton

TINNI-CALM 
carboneum, sulphuratum, chamomilla, chininum, sulphuricum, salicylicum acidum, silicea oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68703-212
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARBON DISULFIDE (UNII: S54S8B99E8) (CARBON DISULFIDE - UNII:S54S8B99E8) CARBON DISULFIDE6 [hp_C]  in 30 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE30 [hp_C]  in 30 mL
HYDROQUININE SULFATE (UNII: F507371PJA) (HYDROQUININE - UNII:31J3Q51T6L) HYDROQUININE SULFATE6 [hp_C]  in 30 mL
MAGNESIUM SALICYLATE (UNII: 41728CY7UX) (SALICYLIC ACID - UNII:O414PZ4LPZ) MAGNESIUM SALICYLATE6 [hp_C]  in 30 mL
MATRICARIA CHAMOMILLA FLOWERING TOP OIL (UNII: SA8AR2W4ER) (MATRICARIA CHAMOMILLA FLOWERING TOP OIL - UNII:SA8AR2W4ER) MATRICARIA CHAMOMILLA FLOWERING TOP OIL6 [hp_C]  in 30 mL
Inactive Ingredients
Ingredient NameStrength
GRAPEFRUIT (UNII: O82C39RR8C)  
LEMON OIL (UNII: I9GRO824LL)  
GRAPE SEED OIL (UNII: 930MLC8XGG)  
GINGER OIL (UNII: SAS9Z1SVUK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68703-212-3030 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product12/14/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic12/14/2016
Labeler - Silver Star Brands (006070379)
Registrant - Silver Star Brands (006070379)
Establishment
NameAddressID/FEIBusiness Operations
Vitality Works137752817manufacture(68703-212)

Revised: 12/2020
Document Id: b6212e7e-b4e4-0044-e053-2995a90ac2ca
Set id: b6212e7e-b4e3-0044-e053-2995a90ac2ca
Version: 1
Effective Time: 20201210
 
Silver Star Brands