Vaseline
FDA Label NDC 64942-0016

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Conopco Inc. D/b/a Unilever for the product Vaseline (NDC 64942-0016). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, 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

Otc - Active Ingredient

Active ingredientWHITE PETROLATUM, USP (99.96%)

Otc - Purpose

Purposeskin protectant

Indications & Usage

Uses￭ helps treat and prevent diaper rash￭ protects chafed skin due to diaper rash￭ helps seal out wetness

Warnings

WarningsFor External Use Only

Otc - Do Not Use

Do not use over deep or puncture wounds, infections or lacerations.  Ask a doctor.

Otc - When Using

When using this product do not get into eyes

Otc - Stop Use

Stop use and ask a doctor if condition worsens or does not improve within 7 days.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.  If swallowed get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions￭ change wet and soiled diapers promptly￭ cleanse diaper area; allow to dry￭ apply product liberally, as often as necessary, with each diaper change and especially at bedtime or anytime when exposure to wet diapers may be prolonged

Inactive Ingredient

Inactive ingredient  FRAGRANCE

Otc - Questions

Questions? Call 1-800-457-7084

Package Label.Principal Display Panel

VPJ Baby 13 oz PDP

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