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.

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Healerz... for Noses

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

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

Other Information

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 AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 g
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALCOHOL (UNII: 3K9958V90M)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
MINERAL OIL (UNII: T5L8T28FGP)  
PARAFFIN (UNII: I9O0E3H2ZE)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
PETROLATUM (UNII: 4T6H12BN9U)  
WHITE WAX (UNII: 7G1J5DA97F)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50485-101-016 in 1 BOX
10.5 g in 1 PACKET
2NDC:50485-101-0224 in 1 BOX
20.5 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: 5/2013
Document Id: 784ef895-d19f-4ab2-a26e-8eab661e4b02
Set id: 96af69b6-42ed-4327-8fa5-a64dfc19d2ec
Version: 2
Effective Time: 20130510
 
Wellco Brands LLC