Inactive Ingredient
Inactive Ingredients aloe barbadensis leaf extract, glycerin, glyceral stearate, methylparaben, mineral oil, petrolatum, propylparaben, sodium lauryl sulfate, stearyl alcohol, water
Thera Cream
FDA Label NDC 55621-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Zhejiang Jingwei Pharmaceutical Co., Ltd. for the product Thera (NDC 55621-001). 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 inactive ingredient, otc - active ingredient, otc - purpose, indications & usage, otc - keep out of reach of children, warnings, otc - stop use, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active Ingredient
Hydrocortisone, USP 1%
Otc - Purpose
Purpose
Anti-itch
Indications & Usage
Uses - for 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 dermatisis
-for external genital, feminine and anal itching
-other uses of this product should be only under the advice and supervision of a doctor
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Warnings
Warnings
for external use only
Otc - Stop Use
Do not use
-in genital area if you have a vaginal discharge. Consult a doctor
-for the treatment of diaper rash. Consult a doctor
Stop use and ask a doctor if
-symptoms last for more than 7 days
-the condition gets worse
-symptoms clear up and then occur again within a few days
-rectal bleeding occurs
Otc - When Using
When using this product
-avoid contact with eyes
-do not use more than directed unless directed by a doctor
-do not put this product into the rectum by using fingers or any other mechanical device or applicator
Dosage & Administration
Directions
for itching of skin irritation, inflammation and rashes:
-adults and children 2 years of age and older: apply to the affected areanot more than 3 to 4 times dailt
-for children udner 2 years of age: ask a doctor
for external anal and genital itching, adults:
-clean the affected area with mild soap and warm water and rinse clean.
-dry the affected area before applying
-apply to the affected area not mroe than 3 to 4 times daily
-children under 12 years of age: ask a doctor
Package Label.Principal Display Panel
Copy Of Label (Zhejiang Hydrolabel)
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