Aloe Cort Cream
FDA Label NDC 51326-108

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topiderm, Inc. for the product Aloe Cort (NDC 51326-108). 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 other, active ingredient, purpose, uses, directions, warnings, otc - keep out of reach of children, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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Other

Drug Facts

Active Ingredient

Hydrocortisone USP 1%

Purpose

Antipruritic cream

Uses

For the temporary relief of itching from minor skin irritations, and rashes

  • Other uses of this product should be only under the supervision of a doctor.

Directions

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily, or as directed. Consult a physician for children under 2 years of age.

Warnings

  • For external use only
  • Avoid contact with the eyes. 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 consult a physician
  • Do not use for treatment of diaper rash

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children. If swallowed, seek professional assistance or contact a Poison Control Center immediately.

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Beeswax, Benzyl Alcohol, Carbomer, Cetearyl Alcohol, Dimethicone, Glycerin, Imidazolidinyl Urea, Methylparaben, PPG-2 Myristyl Ether Propionate, Polysorbate-60, Propylparaben, Purified Water, Squalane, Triethanolamine.

Principal Display Panel - 57 G Tube Label

DERMA
TOPIX

aloe cort cream

Hydrocortisone USP, 1%

Net wt. 2 oz. (57g)

Topix Pharmaceuticals, Inc. • N. Amityville, NY 11701

DERMA
TOPIX

Principal Display Panel (57 g Tube Label)

Principal Display Panel (57 g Tube Label)

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