Active Ingredient
Mineral Oil
Humco Mineral Oil Light Liquid
FDA Label NDC 0395-1673
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Humco Holding Group, Inc. for the product Humco Mineral Oil Light (NDC 0395-1673). 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, purpose, use, warnings, when using this product, keep out of reach of children., directions, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Skin Protectant
Use
Help treat and prevent diaper rash. Protects chafed skin due to diaper rash and, helps seal out wetness.
Warnings
For external use only. For internal use we suggest Humco Mineral Oil Heavy USP.
Avoid contact with eyes. In case of eye contact, flush eyes with running water for 15 minutes.
When Using This Product
Discontinue use if diaper rash worsens or does not improve and contact doctor.
Keep Out Of Reach Of Children.
In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.
Directions
Change wet or soiled diapers promptly. Cleanse the diaper area and allow to dry. Apply mineral oil liberally as often as necessary, with each diapper change, especially at bed time or when exposure to wet diapers may be prolonged.
Inactive Ingredient
dl-alpha tocopherol as a preservative.
Other Information
Keep tightly closed and protect from direct sunlight.
Principal Display Panel
label
Image Description (L167328001 Mineral Oil Light Web)
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