Active Ingredient
MENTHOL 0.9%
Medicated Lip Balm Stick
FDA Label NDC 26052-029
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Burt's Bees, Inc. for the product Medicated Lip Balm (NDC 26052-029). 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, uses, warnings, when using this product, keep out of reach of chuildren, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
EXTERNAL ANALGESIC
Uses
FOR THE TEMPORARY RELIEF OF PAIN AND ITCHING ASSOCIATED WITH FEVER BLISTERS AND COLD SORES
Warnings
FOR EXTERNAL USE ONLY.
IF CONDITION WORSENS OR IF SYMPTOMS PERSIST FOR MORE THAN 7 DAYS OR CLEAR UP AND OCCUR AGAIN WITHIN A FEW DAYS, DISCONTINUE USE AND CONSULT A DOCTOR.
When Using This Product
AVOID CONTACT WITH EYES
Keep Out Of Reach Of Chuildren
IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.
Directions
ADULTS AND CHILDREN 2 YEARS OF AGE AND OLDER: APPLY TO AFFECTED AREA NOT MORE THAN 3 TO 4 TIMES DAILY.
CHILDREN UNDER 2 YEARS OF AGE: CONSULT A DOCTOR.
Inactive Ingredients
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, BEESWAX, CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, RICINUS COMMUNIS (CASTOR) SEED OIL, EUPHORBIA CERIFERA WAX, EUCALYPTUS GLOBULUS LEAF OIL, BUTYROSPERMUM PARKII (SHEA) BUTTER, LANOLIN, CANOLA OIL, COPERNICA CERIFERA WAX, CITRIC ACID, GLYCINE SOJA (SOYBEAN) OIL, MELALEUCA ALTEMIFOLIA (TEA TREE) LEAF OIL, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT, TOCOPHEROL, LIMONENE, LINALOOL.
Other Information
STORE AT ROOM TEMPERATURE
Pdp
BURTS BEES
MEDICATED
LIP BALM WITH MENTHOL AND EUCALYPTUS
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