Active Ingredient (In Each Gram)
Hydrocortisone Acetate USP 1% w/w
Elixircortirelief Cream
FDA Label NDC 84546-0005
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Elixir Healthcare Usa, Llc. for the product Elixircortirelief (NDC 84546-0005). 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 (in each gram), purpose, uses, warnings, do not use, ask a doctor before use in case of, stop use and ask a doctor if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anti-Itch Cream
Uses
For temporary relief of minor skin irritations, itching and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewellery, for external genital, feminine and anal itching
Warnings
For external use only
Do Not Use
• In the eyes
• For diaper rash
If you have vaginal discharge, more then recommended dosage.
Ask A Doctor Before Use In Case Of
• you are pregnant or breast-feeding
Stop Use And Ask A Doctor If
• the condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Adults and children over 2 years of age
• Apply evenly to affected area no more than 3 to 4 times daily
Children under 2 years of age.Do not use. Consult a doctor.
• Adults.When practical, Clean the affected area with mild soap and warm water and rinse thoroughly. Gently dry, patting or blotting with bathroom tissue or soft cloth before applying. Apply externally to the area upto 6 times daily or after each bowel movement. After application, discard pad. Do not flush in toilet.
Inactive Ingredients
Cetomacrogol-1000, Cetostearyl Alcohol, Chlorocresol, Edetate Disodium, Liquid Paraffin, Propylene Glycol, Purified Water, Sodium Metabisulphite, White Soft Paraffin.
Other Information
Store at 20°-25°C (68°-77°F)
avoid excessive heat and humidity
Principal Display Panel
Reorder No. xxxx
Elixir
Hydrocortisone Cream 1%
Anti-Itch Cream
Net Wt. 1 OZ. (28.3G)
Tube-box (Tube Box)
Elixir
Hydrocortisone Cream 1%
Anti-Itch Cream
Maximum Strength
16 oz (454 g)
24 Jars
itching and rashes
Relief of minor skin irritation
NDC: 84546-0005-01
Net Wt. 16 OZ. 9454G)
Reorder No:
MPR-XXXXX
Image Description (Jars Label)
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