Active Ingredient
Petrolatun 30%
Baby Balm Stick 0.65oz Ointment
FDA Label NDC 58503-203
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by China Ningbo Shangge Cosmetics Technology Corp. for the product Baby Balm Stick 0.65oz (NDC 58503-203). 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, stop use and ask a doctor if, do not use on, 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
Skin Protectant (Ointment)
Use
temporarily protects minor;
cut
scrapes
burns
temporarily protects and helps relieve chapped or cracked skin and lips
helps protect from the drying effects of wind and cold weather
Warnings
For external use only
When Using This Product
When using this product do not get into eyes.
Stop Use And Ask A Doctor If
condition worsens
symptoms last more than 7days or clear up and occur again within a few days.
Do Not Use On
deep or puncture wounds
animal bites
serious burns
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Apply as needed.
Inactive Ingredients
Mineral Oil
polyisobutene
polyisobutene
beeswax
microcrystalline wax
butyrospermum parkii (shea butter) oil
BHT
Bisabolol
Glycerin
Tocopherol
Panthenol
Other Information
For best product quality, store below 113°F/45°C.
* Please review the disclaimer below.
