Early Mommy Baby Bum Butta Ointment
FDA Label NDC 81638-171

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Tekt Tone Labs Llc for the product Early Mommy Baby Bum Butta (NDC 81638-171). 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 drug facts, active ingredient, purpose, uses, warnings, do not use on, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient

Zinc Oxide 14%

Purpose

Skin protectant

Uses

  • Temporarily protects minor:
  • cuts
  • scrapes
  • burns
  • Temporarily protects chapped or cracked skin.
  • Dries the oozing and weeping of poison:
  • ivy
  • oak
  • sumac

Warnings

For external use only

Do Not Use On

  • deep or puncture wound
  • animal bites
  • serious burns

When Using This Product

  • do not get into eyes.

Stop Use And Ask A Doctor If

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

If Pregnant Or Breast-Feeding,

ask a health professional before use

Directions

  • apply as needed

Inactive Ingredients:

Beeswax, Cholecalciferol (Vitamin D3), Glycerin, Lanolin, Oat Protein, Petrolatum, Retinyl Palmitate (Vitamin A), Zea Mays (Corn) Starch

Other Information:

  • Protect the product in this container from excessive heat and direct sun.

Questions?

1-732-852-2596

Package Labeling:

Label (Label)

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