SHING-RELEEV  - benzalkonium chloride liquid 
Merix Pharmaceutical Corp.

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:

Benzalkanium Chloride .13%
Allantoin .5%
Benzyl Alcohol .5%

USES:

For the relive of symtoms associated with shingles including pain, Burning, Itching and tingling First aid to help guard against secondary skin infection due to shingles.

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:


If swallowget medical help or contact a Poison Control Center right away.






DIRECTIONS:

Use at first sign of irritation or itching.

Adults and children 12  years or older. Clean without soap.
apply liberally to clean dry area free of soap or cleanser residue.


Apply to area as needed  3-4  times daily.
Do not use cotton applicator.
May be used with sterile bandage after area is dry.






Other Ingredients

.Methylparaben Potassium Sorbate (natural preservative ).

Propylparaben , Viracea (proprietary Echinacea purpurea extract),

water (purified)

Shing carton

Shing Carton approved

SHING-RELEEV  
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63287-420
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
Allantoin (UNII: 344S277G0Z) (Allantoin - UNII:344S277G0Z) Allantoin5 mg  in 1 mL
Benzyl Alcohol (UNII: LKG8494WBH) (Benzyl Alcohol - UNII:LKG8494WBH) Benzyl Alcohol5 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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63287-420-021 in 1 BOX
1NDC:63287-420-0160 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/14/2010
Labeler - Merix Pharmaceutical Corp. (158385687)
Registrant - Topical Pharmaceutiocals Inc. (831530683)
Establishment
NameAddressID/FEIBusiness Operations
Topical Pharmaceutiocals Inc.831530683manufacture(63287-420)

Revised: 7/2012
Document Id: 9f42dc8f-e1fb-4514-92dd-bb55fab3ea3f
Set id: 3ba711f7-8ff8-42fb-958e-51008cd18e75
Version: 9
Effective Time: 20120730
 
Merix Pharmaceutical Corp.