Topical Pharmaceuticals Inc. DRUGS FACTS

Drug Labeling and Warnings

Drug Details [pdf]

THROAT-RELEEV (HONEY AND LEMON)- 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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DRUGS FACTS

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.

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.










Throat Releev Honey Lemon label

Throat Releev Honey Lemon cropped

THROAT-RELEEV (HONEY AND LEMON) 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 15478-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzalkonium Chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y) Benzalkonium Chloride1.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorHONEY (Honey Flavor) , LEMON (Lemon flavosr) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 15478-003-066.0 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/14/201012/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/14/201012/31/2019
Labeler - Topical Pharmaceuticals Inc. (831530683)

Revised: 1/2020
 
Topical Pharmaceuticals Inc.