Hydrophor
FDA Label NDC 54162-500

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Geritrex Llc for the product Hydrophor (NDC 54162-500). 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, directions, dosage & administration, warnings, inactive ingredient, storage and handling, otc - 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

Drug Facts

Active Ingredients: Petrolatum 42%
Purpose: Skin protectant

Uses

• Rehydrates dry, chapped or chafed
skin.
• May be used alone as a skin lubricant
or protectant.

Directions

Apply generously to affected areas
or as directed by your physician.

Dosage & Administration

Apply generously to affected area

Warnings

For External Use Only.
When using this product:
• Avoid contact with eyes.
• If the condition worsens,
discontinue use and contact a
physician.

Inactive Ingredient

Ceresin, Lanolin Alcohol,
Microcrystalline Wax, Mineral Oil,
Phenoxyethanol

Storage And Handling

Store at room temperature (59°F-86°F).

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN.

* Please review the disclaimer below.