HEALERZ FOR NOSES- benzalkonium chloride and lidocaine hydrochloride cream 
Wellco Brands LLC

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.

----------

Drug Facts

Active IngredientsPurpose
Benzalkonium Chloride 0.13%First Aid Antiseptic
Lidocaine HCl 0.5%Pain Relieving Cream

Uses

First aid to help prevent skin infection and for the temporary relief of pain in

  • minor cuts
  • scrapes
  • burns

Warnings

For external use only.

Keep out of reach of children. If ingested, get medical help or contact a Poison Control Center right away.

Do not use

  • in eyes
  • in large quantities
  • over raw or blistered areas, or on deep puncture wounds, animal bites, serious burns
  • for more than one week unless directed by a doctor

Stop use and ask a doctor if

  • the condition gets worse
  • condition clears up and recurs within a few days
  • condition persists for more than 7 days

Directions

  • adults and children 2 years and older: clean affected area, apply small amount not more than 3 to 4 times daily
  • children under 2 years: do not use, consult a doctor

Other Information

  • store at room temperature (do not freeze)
  • Do not use any opened or torn packets

Inactive Ingredients

aloe vera, emulsifying wax, ethyl alcohol, methylparaben, mineral oil, paraffin, propylparaben, purified water, white petrolatum, white wax

Distributed By
WellcoBrands
Buffalo, NY 14221

PRINCIPAL DISPLAY PANEL - 0.5 g Packet Box

Healerz™
... For Noses

Chapped Skin Relief with Pain Reliever

Antiseptic / Pain Relief Cream

6Packets 0.018 oz (0.5g) each

Principal Display Panel - 0.5 g Packet Box
HEALERZ FOR NOSES 
benzalkonium chloride and lidocaine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50485-101
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE1.3 mg  in 1 g
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
ALCOHOL 
METHYLPARABEN 
MINERAL OIL 
PARAFFIN 
PROPYLPARABEN 
WATER 
PETROLATUM 
WHITE WAX 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:50485-101-016 in 1 BOX
10.5 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart333A11/01/2012
Labeler - Wellco Brands LLC (078463203)
Establishment
NameAddressID/FEIBusiness Operations
Safetec of America, Inc.874965262MANUFACTURE(50485-101)

Revised: 08/2012
Document Id: d94ba4c7-bd51-4d38-81aa-06c6cfa7881a
Set id: 96af69b6-42ed-4327-8fa5-a64dfc19d2ec
Version: 1
Effective Time: 20120815
 
Wellco Brands LLC