Drug Facts
Active Ingredients
Hydrocortisone, USP 1%
Hydrocortisone Ointment
FDA Label NDC 13709-316
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Neilmed Pharmaceuticals Inc for the product Hydrocortisone (NDC 13709-316). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, purpose, uses:, warnings:, stop use and ask a doctor if :, keep out of reach of children., directions, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anti-Itch
Uses:
for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:
���� eczema ���� insect bites ���� poison ivy ���� poison oak ���� poison sumac ���� soaps ���� jewelry ���� detergents ���� cosmetics
���� psoriasis ���� seborrheic dermatitis ���� for external genital, feminine and anal itching ���� other uses of this product should be only
under the advice and supervision of a doctor
Warnings:
For external use only.
Do not use:
����for external feminine itching if you have a vaginal discharge. Consult a doctor.
����for the treatment of diaper rash. Consult a doctor.
When using this product
����avoid contact with the eyes
����do not begin the use of any other hydrocortisone product unless directed by a doctor
����for external anal itching: ��������do not use more than directed unless directed by a doctor ��������do not put this product into the rectum by using fingers or any mechanical device or applicator.
Stop Use And Ask A Doctor If :
Stop use and ask a doctor if
��������symptoms last for more than 7 days. ��������the condition gets worse ��������symptoms clear up and occur again in a few days ��������rectal bleeding occurs, consult doctor promptly
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away. 1-800-222-1222
Directions
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, consult a doctor
If pregnant or breast-feeding ���� ask a health professional before use.
For external anal itching
Adults: when practical, clean the affected 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 12 years of age: consult a doctor
Storage And Handling
Storage temperature: not to exceed 30°C (86°F).
Other Information
Before using any medication, read all label directions.
Keep carton, it contains important information.
Inactive Ingredients
mineral oil, white petrolatum.
Safe Handling Warning
TAMPER EVIDENT DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING
Package Label.Principal Display Panel
Hydrocortisone Ointment (Pk Ic102 Rev1 Hydrocortoint Box Page 0001)
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