HYDROCORTISONE: Package Insert and Label Information

HYDROCORTISONE- hydrocortisone cream
Kinray Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active Ingredient Purpose

Hydrocortisone 1% Antipruritic (anti-itch)

Warnings:

For external use only

Purpose

Hydrocortisone is for temporary relief of;


minor skin irritations
Itching and rashes due to;
eczema
insect bites
poison ivy
poison oak
poison sumac
soaps
detergents
cosmetics
jewelry

and for external itching of;
genital
feminine andanal itching

HYDROCORTISONE Indications and Usage

  • in the eyes
  • longer than 1 week unless directed by a physician
  • for diaper rash
  • if you have vaginal discharge
  • more than the recommended daily dosage unless directed by a doctor
  • in the rectum bu using fingers or any other mechanical device or applicator
  • For temporary relief of minor skin irritations and external itching.

Stop use and ask a physician if:

  • the condition persists or gets worse
  • symptoms clear up and occur again within a few days
  • you are pregnant or breast feeding

Keep out of reach of children

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

Dosage and Administration

Adults and children over 2 years of age

  • Apply evenly to affected area no more than 3 or 4 times daily.
Children under 2 years of age
  • Do not use
  • consult a physician
Adults
  • When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
  • Gently dry, patting and blotting with bathroom tissue or soft cloth before applying
  • apply externally to the area up to 6 times daily or after each bowel movement

Other information:

  • Store at 20 deg — 25 deg C (68 deg — 77 deg F)
  • Avoid excessive heat and humidity

Inactive Ingredients

Inactive Ingredients: Cetostearyl alcohol, glyceryl monostearate, mrthylchloroisothiazolinone, propylene glycol, purified water, stearic acid, triethanolamine, white soft paraffin.

Principal Display Panel

KR-1139

Hydrocortisone248.jpg

Hydrocortisone
(click image for full-size original)
HYDROCORTISONE hydrocortisone cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63777-248
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE 1 g in 100 g
Inactive Ingredients
Ingredient Name Strength
CETOSTEARYL ALCOHOL
METHYLCHLOROISOTHIAZOLINONE
PARAFFIN
STEARIC ACID
WATER
PROPYLENE GLYCOL
TROLAMINE
GLYCERYL MONOSTEARATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63777-248-01 28.4 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 06/14/2017
Labeler — Kinray Inc. (012574513)
Registrant — Dynarerx Corporation (008124539)

Revised: 06/2017 Kinray Inc.

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