Carmex Classic Lip Balm Medicated Kit
FDA Label NDC 10210-0096

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Carma Laboratories, Inc. for the product Carmex Classic Lip Balm Medicated (NDC 10210-0096). 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 ingredients, purpose, uses, warnings, keep out of reach of children., directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients

Camphor 1.70%
White Petrolatum 45.30%

White Petrolatum 41.25%

Purpose

External Analgesic
Lip Protectant

Lip Protectant

Uses

  • helps provide relief of symptoms of cold sores and dry lips
    • helps prevent, protect, and relieve chapped lips

Warnings

Keep Out Of Reach Of Children.

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

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

Directions

  • apply to lips not more than 3 to 4 times daily
  • children under 2 years of age: ask a doctor
    • apply as needed

Inactive Ingredients

lanolin, beeswax, cetyl esters, paraffinum liquidum, theobroma cacao seed butter, menthol, salicylic acid, phenol, vanillin, flavor

lanolin, theobroma cacao (cocoa) seed butter, euphorbia cerifera (candelilla) cera, limnanthes alba (meadowfoam) seed oil beeswax, cetyl esters, ozokerite, paraffin, camphor, menthol, salicylic acid, phenol, flavor, vanillin

Package Labeling:

Label (Label)

Label (Label)

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