MEDICATED LIP BALM- menthol and eucalyptus stick

MEDICATED LIP BALM by

Drug Labeling and Warnings

MEDICATED LIP BALM by is a Otc medication manufactured, distributed, or labeled by Burt's Bees, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

MENTHOL 0.9%

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

INGREDIENTS AND APPEARANCE

MEDICATED LIP BALM 
menthol and eucalyptus stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 26052-029
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.9 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SUNFLOWER OIL (UNII: 3W1JG795YI)
WHITE WAX (UNII: 7G1J5DA97F)
EUCALYPTUS OIL (UNII: 2R04ONI662)
SHEA BUTTER (UNII: K49155WL9Y)
LANOLIN (UNII: 7EV65EAW6H)
CASTOR OIL (UNII: D5340Y2I9G)
CARNAUBA WAX (UNII: R12CBM0EIZ)
TEA TREE OIL (UNII: VIF565UC2G)
CANDELILLA WAX (UNII: WL0328HX19)
SAFFLOWER OIL (UNII: 65UEH262IS)
CANOLA OIL (UNII: 331KBJ17RK)
SOYBEAN OIL (UNII: 241ATL177A)
ROSMARINUS OFFICINALIS FLOWERING TOP (UNII: 8JM482TI79)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 26052-029-02	1 in 1 CARTON	01/04/2016
1	NDC: 26052-029-01	4.25 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 26052-029-03	2 in 1 CARTON	01/04/2016
2		4.25 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 26052-029-04	4.25 g in 1 TUBE; Type 0: Not a Combination Product	01/04/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/04/2016

Labeler - Burt's Bees, Inc. (613480946)