Mineral Oil Light, N.f
FDA Label NDC 54162-185

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 Mineral Oil Light, N.f (NDC 54162-185). 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:, use:, warnings, dosage & administration, inactive ingredient, storage and handling, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient:

Mineral Oil 100%   

Use:

Helps treat and prevent diaper rash, protects chafted skin and seals out wetness.

Warnings

​Caution: For External Use Only

​In case of accidental ingestion seek professional assistance or contact a Poison Control Center immediately. Avoid contact with eyes. In case of accidental eye contactl flush eyes gently with water for 15 minutes. Obtain medical attention if irritation persists. If diaper rash worsens or does not improve consult a physician

Dosage & Administration

Clean area thoroughly and allow to dry. Apply mineral oil liberally and as often as needed. Protects the skin against wetness.

Inactive Ingredient

Contains:

dl-alpha-tocopherol as preservative. Keep tightly closed and protect from direct sunlight.

Storage And Handling

Store at room temperature 15-30°C (59-86°F)

Package Label.Principal Display Panel



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