HYDROCORTISONE- hydrocortisone lotion 
Qualitest Pharmaceuticals Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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WARNINGS: For external use only. Avoid contact with eyes. If conditions worsen, or if symptoms persist for more than 1 days or clear up and occur again within a few days, stop use of this product and do not begin use of any other hydrocortisone product unless you have consulted a physician. Do not use for the treatment of diaper rash. Consult a physician

hydrocortisone

Purpose

Anti-itching Lotion

Keep out of reach of children

USUAL DOSAGE: Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: Do not use, consult a physician.

INDICATIONS: For !he temporary relief of itching associated with minor skin irritations and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis or psoriasis. Other uses of this product should be only under the advice or supervision of a doctor.

NDC 0603-7784-54
HYDROCORTISONE LOTION 1%

SNAKE WEll
Antipruritic
Anti-itch lotion

Each gram contains 10 mg of Hydrocortisone in a water washable lotion base of: Water, Propylene Glycol, TEA Stearate, Mineral Oil, Glyceryl Stearate SE, Acetylated Lanolin Alcohol, Cetyl Acetate, Lanolin Alcohol, Choleth-24, Ceteth-24, Carbomer 934, Methylparaben, Propylparaben, Diazolidinyl Urea.
NET CONTENTS
4 fl oz.(118.3 ml)

bottle.jpgBottle

HYDROCORTISONE 
hydrocortisone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0603-7784
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE1 g  in 100.65 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
Packaging
#Item CodePackage Description
1NDC:0603-7784-5412 in 1 CASE
1118.3 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/01/199805/05/2010
Labeler - Qualitest Pharmaceuticals Inc. (011103059)
Registrant - Harmony Labs, Inc. (105803274)
Establishment
NameAddressID/FEIBusiness Operations
Harmony Labs, Inc.105803274manufacture(0603-7784), label(0603-7784), pack(0603-7784), relabel(0603-7784), repack(0603-7784)

Revised: 04/2013
 
Qualitest Pharmaceuticals Inc.