Maybelline New York Baby Lips Dr Rescure Menthol External Analgesic Medicated Balm Lipstick
FDA Label NDC 49967-494

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 Rescure Menthol External Analgesic Medicated Balm (NDC 49967-494). 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

Active Ingredient

Menthol 0.5%

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

Polybutene, Octyldodecanol, Petrolatum, Isopropyl Myristate, Polyethylene, Ozokerite, Diisostearyl Malate, Butyrospermum Parkii (Shea) Butter, Euphorbia Cerifera (Candelilla) Wax, Vp/Hexadecene Copolymer, Eucalyptus Globulus Leaf Oil, Pentaerythrityl Tetra-Di-T-Butyl Hydroxyhydrocinnamate, Tocopherol, Tocopheryl Acetate, Alumina, Limonene, Aluminum Hydroxide, Synthetic Fluorphlogopite, Calcium Sodium Borosilicate, Calcium Aluminum Borosilicate, Silica, Honey, Centella Asiatica Extract, Dimethicone, Tin Oxide, Bht, Citric Acid, Titanium Dioxide, Iron Oxides, Red 22 Lake, Red 7, Red 28 Lake, Mica, Yellow 5 Lake, Yellow 6 Lake, Blue 1 Lake, Carmine

Questions Or Comments?

1-800-322-2036 Monday - Friday (9 a.m. - 5 p.m. EST)

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