Hydrocortisone by Morales Distributors Inc HYDROCORTISONE cream

Hydrocortisone by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredient

Hydrocortisone 1.0 percent

Purpose

Anti-Itch

Uses

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

• eczema
• psoriasis
• seborrheic dermatitis
• poison ivy, oak, sumac
• insect bites
• soaps and detergents
• cosmetics
• jewerly
• external feminine and anal itching

Other uses of this product: ask a doctor

Warnings

For external use only

Do not use

• in or near the eyes
• by putting directly into the rectum by using fingers or any mechanical device or applicator
• for external feminine itching if you have a vaginal discharge
• for diaper rash; ask a doctor
  

Ask a doctor or pharmacist

before use if you are using any other hydrocortisone product

When using this product

for external anal itching, do not exceed recommended daily dosage unless directed by a doctor

Stop use and ask a doctor if

• condition worsens or does not improve within 7 days
• symptoms clear up and return within a few days
• rectal bleeding occurs

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control

Directions

• apply to affected area not more than 3 to 4 times daily
• for external anal itching: when practical, clean area with mild soap and warm water, rinse thoroughly, gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
• children under 2 years, or children under 12 years with external anal itching, do not use, ask a doctor
  

Other information

store at room temperature, protect from freezing

Inactive ingredients

butylated hydroxytoluene, cetyl alcohol, glycerin, glyceryl monostearate, isopropyl myristate, methylparaben, propylparaben, purified water, squalane, and stearic acid

Principal Label

NDC NO. 53210-1002-0
Compare to maximum strength Cortaid(R) active ingredient

Maximum Strength
FAST RELIEF
plus itching plus redness

Anti-Itch Cream for Skin Irritations

Relieves Itching and Redness Fast

Hydrocortisone 1 percent Cream

NET 1oz(28.3g)

Exclusively distributed by:
Morales Distributors, Inc
Mayaguez, P.R. 00682

This product is not manufactured or distributed by Pharmacia Consumer Healthcare, owner of the registered trademark Cortaid.(R)

Made in Korea

INGREDIENTS AND APPEARANCE

HYDROCORTISONE  
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53210-1002
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
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SQUALANE (UNII: GW89575KF9)
STEARIC ACID (UNII: 4ELV7Z65AP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53210-1002-0	1 in 1 BOX
1		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	09/25/2012

Labeler - Morales Distributors Inc (127151731)