HYDROCORTISONE D- hydrocortisone cream

Hydrocortisone by

Drug Labeling and Warnings

Hydrocortisone by is a Otc medication manufactured, distributed, or labeled by NexMed (USA), Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Hydrocortisone 1%

Purpose

Anti-itch cream

Uses

• For the temporary relief of itching associated with minor skin irritations, inflammation and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, scrapes
• for external genital, feminine and anal itching
• other uses of this product should be only under the advice and supervision of a doctor

Warnings

For external use only.

When using this product

• avoid contact with the eyes
• do not put this product into the rectum by using fingers or any mechanical device or applicator
  

Stop use and ask a doctor if

• condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor
  
• rectal bleeding occurs
  

Do not use

• for the treatment of diaper rash. Ask a doctor
• in the genital area if you have vaginal discharge. Ask a doctor

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away

Directions

• For 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 doctor
• Adults for external anal itching when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with an appropriate cleansing pad
• Gently dry by patting or blotting toilet tissue or a soft cloth before application of this product
• Children under 12 years of age: for external itching consult a doctor

Other information

Store between 20⁰ and 25⁰C (68⁰ to 77⁰F)

Inactive Ingredients

citric acid, dodecyl-2-N N-dimethylaminopropionate hydrochloride, glycerin, glycerol stearate, methylparaben, petrolatum, polysorbate 80, propylene glycol, propylparaben, purified water, sodium citrate, titanium dioxide

Questions?

Call 1-800-866-7391, Mon-Fri, 8:30 AM - 5:30 PM (PST)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HYDROCORTISONE  D
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 40002-003
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
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Dodecyl-2-N,N-Dimethylaminopropionate Hydrochloride (UNII: 18F5YMF989)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
METHYLPARABEN (UNII: A2I8C7HI9T)
PETROLATUM (UNII: 4T6H12BN9U)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 40002-003-02	1 in 1 CARTON
1	NDC: 40002-003-03	28 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/19/2011

Labeler - NexMed (USA), Inc. (031710528)

Registrant - NexMed (USA), Inc. (031710528)