Topical Pharmaceuticals Inc. DRUGS FACTS

Drug Labeling and Warnings

Drug Details [pdf]

SHING-RELEEV - 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:

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 approved.jpg

SHING-RELEEV  
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 15478-005
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
Allantoin (UNII: 344S277G0Z) (Allantoin - UNII:344S277G0Z)	Allantoin	5 mg  in 1 mL
Benzyl Alcohol (UNII: LKG8494WBH) (Benzyl Alcohol - UNII:LKG8494WBH)	Benzyl Alcohol	5 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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 15478-005-02	1 in 1 BOX	07/14/2010	12/31/2019
1	NDC: 15478-005-01	60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

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(15478-005)

Revised: 1/2020

Document Id: bb2e77a3-788a-4e3d-a468-261de7176bca

34390-5

Set id: 016c9977-9803-4830-be48-222bdc0e24fd

Version: 2

Effective Time: 20200131

 

Topical Pharmaceuticals Inc.