Purpose
Antipruritic (Anti-itch)
Hydrocortisone Cream 1%
FDA Label NDC 70512-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sola Pharmaceuticals for the product Hydrocortisone Cream 1% (NDC 70512-101). 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 purpose, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
Relieves itches and rashes due to:
- Eczema
- Psoriasis
- Seborrheic dermatitis
- Poison ivy
- Poison oak
- Poison sumac
- Insect bites
- External anal itching
- Soaps
- Detergents
- Cosmetics
- Jewelry
Temporary relief of external anal and genital itching.
Other use of the product should only be under the advice and supervision of a doctor.
Warnings
For external use only
Do not use:
- In the eyes
- For diaper rash
- If you have vaginal discharge
- More than the recommended dosage
- If you are pregnant or breast feeding
- Condition worsens, or is symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor.
- Do not put this product into rectum by using fingers or any mechanical device or applicator.
Ask doctor before use:
Stop use and ask a doctor if:
When using this product:
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away
Directions
- Adults and children over 2 years of age - Apply to affected area not more than 3-4 times per day.
- Children under 2 years of age - Do not use. Consult a doctor.
- For external anal itching Adults - When practical cleanse the affcted area with mild soap and water and rinse thoroughly. Gently dry patting with bathroom tissue or soft cloth before applying. Apply to affected area not more than 3-4 times per day. Children under 12 years of age: consult a doctor.
Other Information
- store between 20°C and 25°C (68°Fk and 77°F)
- avoid excessive heat and humidity
Inactive Ingredients
Cetomacrogol 1000, Cetostearyl alcohol, Chlorocresol, Disodium EDTA, Liquid paraffin, Propylene glycol, Purified water, Sodium metabisulphite, White soft paraffin.
Package Label.Principal Display Panel
Questions of comments? Call 1-866-747-7365
Manufactured for : SOLA Pharmaceuticals
Baton Rouge, LA 70810
Store in a dry, cool place
Hydrocortisone 1% Cream
NDC 70512-101-30
Qty: 28.4g
* Please review the disclaimer below.
