Medicated Lip Balm (menth & Euc)

Medicated Lip Balm (menth & Euc)
SPL v4
SPL
SPL Set ID 30da3cc5-6140-2dee-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2016-04-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (0.9 g)
Inactive Ingredients
Anhydrous Citric Acid Sunflower Oil White Wax Eucalyptus Oil Shea Butter Lanolin Castor Oil Carnauba Wax Tea Tree Oil Candelilla Wax Safflower Oil Canola Oil Soybean Oil Rosmarinus Officinalis Flowering Top Tocopherol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-01-04

Description

MENTHOL 0.9%

Purpose

EXTERNAL ANALGESIC


Medication Information

Purpose

EXTERNAL ANALGESIC

Description

MENTHOL 0.9%

Pdp

BURTS BEES

MEDICATED

LIP BALM WITH MENTHOL AND EUCALYPTUS

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.

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.

Active Ingredient

MENTHOL 0.9%

Other Information

STORE AT ROOM TEMPERATURE

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.

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.


Structured Label Content

Pdp (PDP)

BURTS BEES

MEDICATED

LIP BALM WITH MENTHOL AND EUCALYPTUS

Uses (USES)

FOR THE TEMPORARY RELIEF OF PAIN AND ITCHING ASSOCIATED WITH FEVER BLISTERS AND COLD SORES

Purpose (PURPOSE)

EXTERNAL ANALGESIC

Warnings (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.

Directions (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.

Active Ingredient (ACTIVE INGREDIENT)

MENTHOL 0.9%

Other Information (OTHER INFORMATION)

STORE AT ROOM TEMPERATURE

Inactive Ingredients (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.

When Using This Product (WHEN USING THIS PRODUCT)

AVOID CONTACT WITH EYES

Keep Out of Reach of Chuildren (KEEP OUT OF REACH OF CHUILDREN)

IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.


Advanced Ingredient Data


Raw Label Data

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