Proheal Hydrocortisone 1% Maximum Strength Plus Aloe Cream
FDA Label NDC 86173-005

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Click Industries Llc for the product Proheal Hydrocortisone 1% Maximum Strength Plus Aloe (NDC 86173-005). 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, active ingredient, purpose, uses:, warnings:, otc - keep out of reach of children, directions, other information:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Drug Facts

Active Ingredient

Hydrocortisone 1%

Purpose

Anti-Itch

Uses:

Temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to: eczema, insect bites, poison ivy, oak, or sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, temporarily relieves external anal and external genital itching, other uses of this product should be only under the advice and supervision of a doctor.

Warnings:

For external use only.

Do not use: • In the genital area if you have a vaginal discharge. Consult a doctor. • For the treatment of diaper rash. Consult a doctor.

When using this product • Avoid contact with eyes • Do not use more than directed unless told to do so by a doctor • Do not put directly into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if • Rectal bleeding occurs • Condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not use this or any other hydrocortisone product unless you have asked 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 immediately.

Directions

For itching of skin irritation, inflammation, and rashes:
• 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, ask a doctor

For external anal and external genital itching, adults:
• When practical, cleanse 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 applying • Apply to affected area not more than 3 to 4 times daily • Children under 12 years of age: ask a doctor

Other Information:

Store at 20-25°C (68-77°F)

Inactive Ingredients:

Aloe barbadensis leaf juice, Cetyl alcohol, Glycerin, Glyceryl stearate SE, Mineral oil, PEG-100 stearate, Phenoxyethanol, Purified water, Stearyl alcohol, White petrolatum, Xanthan gum.

Packaging

Hydrocortisone1%aloe (86173005 1)

Hydrocortisone1%aloe (86173005 1)

* Please review the disclaimer below.