MAYBELLINE NEW YORK BABY LIPS DR RESCURE MENTHOL EXTERNAL ANALGESIC MEDICATED BALM- menthol lipstick

Maybelline New York BABY LIPS DR RESCURE MENTHOL EXTERNAL ANALGESIC MEDICATED BALM by

Drug Labeling and Warnings

Maybelline New York BABY LIPS DR RESCURE MENTHOL EXTERNAL ANALGESIC MEDICATED BALM by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, L'OREAL USA PRODUCTS, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MAYBELLINE NEW YORK BABY LIPS DR RESCURE MENTHOL EXTERNAL ANALGESIC MEDICATED BALM 
menthol lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-494
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
OCTYLDODECANOL (UNII: 461N1O614Y)
PETROLATUM (UNII: 4T6H12BN9U)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
SHEA BUTTER (UNII: K49155WL9Y)
CANDELILLA WAX (UNII: WL0328HX19)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
EUCALYPTUS OIL (UNII: 2R04ONI662)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
TOCOPHEROL (UNII: R0ZB2556P8)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALUMINUM OXIDE (UNII: LMI26O6933)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
CALCIUM SODIUM BOROSILICATE (UNII: 4MM76N4WMY)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HONEY (UNII: Y9H1V576FH)
CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)
DIMETHICONE (UNII: 92RU3N3Y1O)
STANNIC OXIDE (UNII: KM7N50LOS6)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
MICA (UNII: V8A1AW0880)
FD&C YELLOW NO. 6 ALUMINUM LAKE (UNII: GYP6Z2JR6Q)
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-494-01	1 in 1 BLISTER PACK	06/01/2016
1		4.4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	06/01/2016

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'OREAL USA PRODUCTS, INC		624244349	manufacture(49967-494)