Hydrocortisone by Discount Drug Mart, Inc. HYDROCORTISONE ointment

Hydrocortisone by

Drug Labeling and Warnings

Hydrocortisone by is a Otc medication manufactured, distributed, or labeled by Discount Drug Mart, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

temporarily relieves itching associated with minor skin irritation, inflammation and rashes due to:

• eczema

• insect bites
• psoriasis

• poison ivy, oak, sumac

• soaps

• detergents

• cosmetics

• jewelry

• seborrheic dermatitis

• temporarily relieves external anal and genital itching
• other uses of this product hould only be under the advice and supervision of a doctor

Warnings

For external use only

Do not use

• if you are allergic to any of the ingredients
• in the genital area if you have a vaginal discharge. Consult a doctor.
• for the treatment of diaper rash. Ask a doctor.
  

When using this product

• avoid contact with eyes
• do not use more than directed unless told to do so by a doctor
• do not put directly 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
  

Keep out of reach of children

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

Directions

for itching of skin irritation, inflammation, and rashes:

• 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: ask a doctor

for external anal and genital itching, adults:

• when practical, clean the affected area with mild soap and warm water, and rinse thoroughly
• gently dry by patting or blotting with toilet tissue or a soft cloth before applying
• apply to affected area not more than 3 to 4 times daily
• children under 12 years of age: ask a doctor
  

Other information

store at room temperature

Inactive ingredient

aloe vera, beeswax, cetyl alcohol, dextrin, glycerin, light mineral oil, maltodextrin, methylparaben, myristoyl/palmitoyl oxosstearamide/archamide MEA, petrolatum, propylparaben, sodium ceteryl sulfate, sodium lauryl sulfate, water

Package label

INGREDIENTS AND APPEARANCE

HYDROCORTISONE 
hydrocortisone ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53943-986
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERIN (UNII: PDC6A3C0OX)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHAMIDE MEA (UNII: 1211AIM8G7)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM CETYL SULFATE (UNII: 3V3Y3O7BIQ)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
WATER (UNII: 059QF0KO0R)
LIGHT MINERAL OIL (UNII: N6K5787QVP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53943-986-01	1 in 1 BOX	10/30/2015
1		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/30/2012

Labeler - Discount Drug Mart, Inc. (047741335)