HEALERZ FOR ITCHES- hydrocortisone 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 Itches

Drug Facts

Active Ingredient

Hydrocortisone 1.0%

Purpose

Anti-itch

Uses

Warnings

For external use only.

Do not use

  • for treatment of diaper rash
  • for feminine itching

Avoid contact with eyes

Stop use and ask a doctor

  • if condition worsens or lasts more than 7 days, or clears up and occurs again within a few days
  • with use of other hydrocortisone products

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

Directions

Other Information

Inactive Ingredients

emulsifying wax, ethanol, methylparaben, mineral oil, paraffin, petrolatum, propylparaben, purified water, white wax

Distributed By
WellcoBrands
716-568-8040
Buffalo, NY 14221

PRINCIPAL DISPLAY PANEL - 6 Packet Carton

Healerz
...For Itches

Fast relief for your scratchy skin

1% Hydrocortisone Anti-Itch Cream

6 Packets 0.018 oz (0.5g) each

Principal Display Panel - 6 Packet Carton
HEALERZ FOR ITCHES 
hydrocortisone cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50485-102
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE 1 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
ALCOHOL (UNII: 3K9958V90M)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
MINERAL OIL (UNII: T5L8T28FGP)  
PARAFFIN (UNII: I9O0E3H2ZE)  
PETROLATUM (UNII: 4T6H12BN9U)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
WHITE WAX (UNII: 7G1J5DA97F)  
Product Characteristics
Color WHITE Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50485-102-01 6 in 1 BOX
1 0.5 g in 1 PACKET
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part348 02/01/2013
Labeler - Wellco Brands LLC (078463203)
Establishment
Name Address ID/FEI Business Operations
Safetec of America, Inc. 874965262 MANUFACTURE(50485-102)

Revised: 1/2013
Document Id: 5fdb1314-c7bc-4543-9fb7-957161bff0ed
Set id: 44574e6f-b4ca-4c86-a12e-a0bef91d4cb0
Version: 1
Effective Time: 20130109
 
Wellco Brands LLC