Active Ingredient
White Petrolatum USP (100%)
Petroleum Jelly
FDA Label NDC 13709-337
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Neilmed Pharmaceuticals Inc. for the product Petroleum Jelly (NDC 13709-337). 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, uses, warnings, do not use on, when using this product, stop use and ask a doctor if, 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
Purpose
White Petrolatum USP (100%).......Skin protectant
Uses
- helps treat and prevent diaper rash
- protects chafed skin due to diaper rash
- helps seal out wetness
Warnings
For external use only
Do Not Use On
- deep or puncture wounds
- animal bites
- serious burns
When Using This Product
do not get into eyes
Stop Use And Ask A Doctor If
condition worsens or does not improve within 7 days.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- change wet and soiled diapers promptly
- cleanse the diaper area, and 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
Fragrance
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