HYDROCORTISONE by Kinray Inc.
Dosage form: cream
Ingredients: HYDROCORTISONE 1g in 100g
Labeler: Kinray Inc.
NDC Code: 63777-248
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)
For external use only
Hydrocortisone is for temporary relief of;
minor skin irritations
Itching and rashes due to;
and for external itching of;
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
Children under 2 years of age
- Apply evenly to affected area no more than 3 or 4 times daily.
- Do not use
- consult a physician
- 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
- Store at 20 deg - 25 deg C (68 deg - 77 deg F)
- Avoid excessive heat and humidity
Inactive Ingredients: Cetostearyl alcohol, glyceryl monostearate, mrthylchloroisothiazolinone, propylene glycol, purified water, stearic acid, triethanolamine, white soft paraffin.
Principal Display Panel
|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
|#||Item Code||Package Description
|1||NDC:63777-248-01||28.4 g in 1 TUBE
|Marketing Category||Application Number or Monograph Citation||Marketing Start Date||Marketing End Date
|OTC monograph not final||part348||06/14/2017||
|Labeler - Kinray Inc.
|Registrant - Dynarerx Corporation (008124539)
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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.