Active Ingredient
Hydrocortisone 1%
Alocane Anti-itch Gel
FDA Label NDC 68229-411
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Quest Products, Llc for the product Alocane Anti-itch (NDC 68229-411). 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 active ingredient, purpose, uses, warnings, stop use and ask a doctor, do not use, kep out of reach of children, directions, 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, inflamation, and rashes due to
- eczema
- insect bites
- poison ivy, poison oake, or poison sumac
- soaps
- detegents
- cosmetics
- jewelry
- seborrheic dermatitis
- psoriasis
- and for external genital, feminine, and anal itching
Warnings
FOR EXTERNAL USE ONLY
When using this product avoid contact with eyes
Stop Use And Ask A Doctor
- if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
- stop use of this product and do not begin use of any other hydrocortisone product unless you have consulted a doctor.
Do Not Use
- for the treatment of diaper rash
- Do not use if you have vaginal discharge. Consult a doctor.
- 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.
Kep Out Of Reach Of Children
If swallowed, get medical help or contact Poison Control Center reight away.
Directions
Adults and Children 2 years of age or older
- Apply to affected area not more than 3 to 4 times daily.
- Adults: when practical, cleans the affected area with mild soap and warm water and rinse thoroughly.
- Gently dry by patting or blotting with toilet tissue or soft cloth before application of this product.
Children under 2 years of age: Do not use, consult a doctor.
Other Information
Store at room temperature 15° - 30° C (59° - 86°F)
Inactive Ingredients
Aloe Barbadensis Leaf Juice, Ethylhexylglycerin, Hypromellose, Phenoxyethanol, Propanediol, SD Alcohol 40-B, Water.
1.5Oz Outer Label
Pdp (Anti Itch Pdp)
* Please review the disclaimer below.
