Active Ingredient
Menthol 0.5%
Maybelline New York Baby Lips Dr Rescue Medicated Balm Lipstick
FDA Label NDC 49967-489
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by L'oreal Usa Products Inc for the product Maybelline New York Baby Lips Dr Rescue Medicated Balm (NDC 49967-489). 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, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
External analgesic
Use
for the temporary relief of pain associated with fever blisters and cold sores
Warnings
For external use only
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.
Directions
for adult use only: apply to affected area not more than 3 to 4 times daily
Inactive Ingredients
octyldodecanol, polybutene, petrolatum, isopropyl myristate, polyethylene, ozokerite, diisostearyl malate, butyrospermum parkii (shea) butter, euphorbia cerifera (candelilla) wax, VP/hexadecene copolymer, eucalyptus globulus leaf oil, penaerythrityl tetra-di-t-butyl hydroxyhydrocinamate, tocopherol, tocopheryl acetate, limonene, honey, centella asiatica extract
Questions Or Comments?
1-800-322-2036 Monday - Friday (9 a.m. - 5 p.m. EST)
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