THROAT-RELEEV (HONEY AND LEMON)- benzalkonium chloride liquid

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENTS

Benzalkonium  Chloride

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.

DOSAGE & ADMINISTRATION

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 honey and lemon flavors.

PRINCIPAL DISPLAY PANEL

Throat Releev Honey Lemon label

INGREDIENTS AND APPEARANCE

THROAT-RELEEV (HONEY AND LEMON) 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63287-211
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 LEAF (UNII: 6TC6NN0876)

Product Characteristics
Color		Score
Shape		Size
Flavor	HONEY (Honey Flavor) , LEMON (Lemon flavosr)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63287-211-03	6.0 mL in 1 BOTTLE, SPRAY

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

Labeler - Merix Pharmaceutical Corp. (158385687)

Registrant - Topical Pharmaceutiocals Inc. (831530683)

Establishment
Name	Address	ID/FEI	Business Operations
Topical Pharmaceutiocals Inc.		831530683	manufacture