Hydrocortisone by Galentic Pharma (India) Private Limited
Dosage form: cream
Ingredients: Hydrocortisone 10mg in 1g
Labeler: Galentic Pharma (India) Private Limited
NDC Code: 50382-024
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.
Temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
- poison ivy, poison oak, poison sumac
- insect bites
- seborrheic dermatitis
- external itching and anal itching.
For external use only
- For the treatment of diaper rash. Ask a doctor
- For external genital itching if you have a vaginal discharge. Ask a doctor
- Avoid contact with the eyes
- Do not begin use of any other Hydrocortisone product unless you have asked a doctor
- For external anal itching do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, consult a doctor promptly.
- Do not put this product into the rectum by using fingers or any mechanical device or applicator
- Condition worsens
- Symptoms persist for more than 7 days or clear up and occur again within a few days
• KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
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. Ask a doctor.
For external anal itching:
- adults: when practical, cleanse 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 application of this product.
- children under 12 years of age with external anal itching: ask a doctor.
- Store at 15° to 30°C (59° to 86°F)
- Lot No. & Exp.Date: See box or crimp of tube.
Cetamacrogol 1000, Cetostearyl Alcohol, Chlorocresol, Liquid Paraffin, Propylene Glycol, Purified Water, White Soft Paraffin
Manufactured by : Galentic Pharma (India) Pvt. Ltd., Plot No. 5-B & 5-C, Sector III, Kandla Special Economic Zone,
Gandhidham-370 230, Gujrat. India
|Labeler - Galentic Pharma (India) Private Limited (915110464)|
|Galentic Pharma (India) Private Limited||864201135||ANALYSIS(50382-024), MANUFACTURE(50382-024), PACK(50382-024), REPACK(50382-024), STERILIZE(50382-024)|
|Galentic Pharma (India) Private Limited||650970176||ANALYSIS(50382-024), MANUFACTURE(50382-024), PACK(50382-024), REPACK(50382-024), STERILIZE(50382-024)|
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.