Petroleum Jelly
FDA Label NDC 36800-519

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Petroleum (NDC 36800-519). 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 ingredients, purpose, uses, warnings, do not use on, when using this product, stop use and ask a doctor, 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

Active Ingredients

White Petrolatum USP (100%)

Purpose

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 soilded diapers promptly
  • cleanse the diaper area, and allow to dry
  • apply product liberally as often as necessary, with each diaper change, and expecially at bedtime or anytime when exposure to wet diapers may be prolonged

Inactive Ingredient

fragrance

Disclaimer

This product is not manufactured or distributed by Unilever, distributer of Vaseline Baby Petroleum Jelly Baby Fresh

Adverse Reaction

DISTRIBUTED BY

TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

1-888-423-0139

tippytoesbytopcare.com

Principal Display Panel

Tippy

Toes

by TopCare

Baby

petroleum 

jelly

skin protectant

helps treat &

prevent diaper rash

baby fresh scent

COMPARE TO VASELINE BABY

NET WT 13 OZ (368g)

Image Description (Mm3)

Image Description (Mm3)

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