Drug Facts
Active ingredient
Hydrocortisone, USP 1%
Purpose
Anti-itch\
The following Structured Product Label (SPL) was submitted to the FDA by Neilmed Pharmaceuticals Inc for the product Intensive Healing Itch Relief (NDC 13709-359). 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, uses, warnings, ask a doctor if, stop use and ask a doctor if, when using this product, if pregnant or breast-feeding, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredient
Hydrocortisone, USP 1%
Purpose
Anti-itch\
eczema
psoriasis
seborrheic dermatitis
poison ivy
poison oak
poison sumac
insect bites
soaps
detergents
cosmetics
jewelry
for external genital, feminine and anal itching
other uses of this product should be only under the advice and supervision of a doctor
For the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:
eczema
psoriasis
seborrheic dermatitis
poison ivy
poison oak
poison sumac
insect bites
soaps
detergents
cosmetics
jewelry
for external genital, feminine and anal itching
other uses of this product should be only under the advice and supervision of a doctor
For external use only
Do not use:
When using this product,
Stop use and ask a doctor if
Do Not Use: For external feminine itching if you have a vaginal discharge. Consult a doctor.
Do Not Use: 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 occur again in a few days; rectal bleeding occurs, consult doctor promptly.
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.
ask a health professional before use
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. 1-800-222-1222.
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.
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 temperature, not to exceed 30°C (86°F). Protect from freezing.
Before using any medication, read all label directions. Keep carton, it contains important information.
aloe vera leaf, ascorbic acid, benzyl alcohol, ceteareth-20, cetearyl alcohol, cetyl palmitate, chamomile extract, glycerin, isopropyl myristate, isostearyl neopentanoate, methyl paraben, PEG-40 stearate, petroleum, purified water, retinyl palmitate, tocopheryl acetate, vitamin D
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. 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.
For external feminine itching if you have a vaginal discharge. Consult a doctor.
For the treatment of diaper rash, consult a doctor.
Intensive Healing Itch Relief Cream
Hydrocortisone 1%
Maximum Strength
24 Hour Moisture
Soothing relief from itching, rashes, redness, inflammation and other skin irritations
NET WT 2 OZ (57 g)
* Please review the disclaimer below.