Your browser does not support JavaScript! HEALERZ FOR ITCHES (HYDROCORTISONE) CREAM [WELLCO BRANDS LLC]
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HEALERZ FOR ITCHES (hydrocortisone) cream
[Wellco Brands LLC]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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 Label Sections

Drug Facts

Active Ingredient

Hydrocortisone 1.0%

Purpose

Anti-itch

Uses

  • temporarily relieves itching associated with minor skin irritations, inflammation and rashes due to:
    • eczema
    • psoriasis
    • poison ivy, oak, sumac
    • insect bites
    • detergents
    • jewelry
    • cosmetics
    • soaps
    • seborrheic dermatitis
  • other uses of product should be only under the advice and supervision of a doctor

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

  • apply to affected area not more than 3 to 4 times daily
  • children under 2 years: ask a doctor

Other Information

  • store at room temperature
  • Do not use any opened or torn packets

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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:50485-102
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
METHYLPARABEN 
MINERAL OIL 
PARAFFIN 
PETROLATUM 
PROPYLPARABEN 
WATER 
WHITE WAX 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50485-102-016 in 1 BOX
10.5 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34802/01/2013
Labeler - Wellco Brands LLC (078463203)
Establishment
NameAddressID/FEIBusiness Operations
Safetec of America, Inc.874965262MANUFACTURE(50485-102)

Revised: 1/2013
 
Wellco Brands LLC

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