Topical Pharmaceuticals Inc. DRUG FACTS

Drug Labeling and Warnings

Drug Details [pdf]

THROAT-RELEEV (CHERRY AND POMEGRANATE)- benzalkonium chloride liquid 
Topical Pharmaceuticals Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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DRUG FACTS

ACTIVE INGREDIENTS

Benzalkonium chloride      
Allantoin

USES:

• For the relive of symtoms associated with sore throat including:

                    pain, Burning, Itching and tingling

• First aid to help guard against secondary skin infection due to sore
  throat.

WARNINGS:

For external used only. Not for ingestion.

Do not used- in yeast infections- do not spray directly on the eyes

When using this product, may tingle on contact.

Stop used and ask doctor if - condition worsens- symptoms

last more then 7 days

KEEP OUT OF REACH OF CHILDREN:

In case of overdose, or accidental poisoning,

get medical help or contact a Poison Control Center right away.

DIRECTIONS:

Adults and children 12  years or older. Shake well.

Direct nozzel to sore throat area and spray 3-4  times.
Do not swallow.
Hold for 15 seconds or longer then spit remaining liquid out.

Other Ingredients

Viracea (proprietary Echinacea purpurea extract). Methylparaben

Potassium Sorbate (natural preservative ). Propylparaben , water (purified)

Stevia, Natural cherry and pomegranate flavors

Throat Releev Cherry Pom cropped

THROAT-RELEEV (CHERRY AND POMEGRANATE) 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 15478-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzalkonium Chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y)	Benzalkonium Chloride	1.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Methylparaben (UNII: A2I8C7HI9T)
Potassium Sorbate (UNII: 1VPU26JZZ4)
Propylparaben (UNII: Z8IX2SC1OH)
Echinacea purpurea flowering top (UNII: 2EMS3QFX65)
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY (Cherry Flavor) , POMEGRANATE (Pomegranate)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 15478-004-06	6.0 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	07/14/2010	12/31/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/14/2010	12/31/2019

Labeler - Topical Pharmaceuticals Inc. (831530683)

Establishment
Name	Address	ID/FEI	Business Operations
Topical Pharmaceuticals Inc.		831530683	manufacture(15478-004)

Revised: 1/2020

Document Id: 68aca114-4448-424a-aa6f-e42523f27c35

34390-5

Set id: 40ab8006-66f0-46d1-b71f-3133a4e85378

Version: 5

Effective Time: 20200131

 

Topical Pharmaceuticals Inc.