HEALERZ FOR ITCHES- hydrocortisone cream

Healerz for Itches by

Drug Labeling and Warnings

Healerz for Itches by is a Otc medication manufactured, distributed, or labeled by Wellco Brands LLC, Safetec of America, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

HEALERZ FOR ITCHES 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50485-102
Route of Administration	TOPICAL

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)