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Drug Facts

Manufacturer
L'Oreal USA Products Inc | L'OREAL USA PRODUCTS, INC
Effective date
2024-06-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:14:41

Label at a glance#

ProductMaybelline New York BABY LIPS DR RESCURE MENTHOL EXTERNAL ANALGESIC MEDICATED BALM
Active ingredientMENTHOL
Label structure10 sections

Dosage and administration

for adult use only: apply to affected area not more than 3 to 4 times daily

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 0.5%

Purpose

OTC - PURPOSE SECTION

External analgesic

Use

INDICATIONS & USAGE SECTION

  • for the temporary relief of pain associated with fever blisters and cold sores

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

do not get into eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • for adult use only: apply to affected area not more than 3 to 4 times daily

Questions or comments?

OTC - QUESTIONS SECTION

1-800-322-2036 Monday - Friday (9 a.m. - 5 p.m. EST)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of a blisterpack front and backimage of a blisterpack front and back

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-494-01Maybelline New York BABY LIPS DR RESCURE MENTHOL EXTERNAL ANALGESIC MEDICATED BALM4.4 g in 1 TUBELIPSTICK4.41
49967-494-01Maybelline New York BABY LIPS DR RESCURE MENTHOL EXTERNAL ANALGESIC MEDICATED BALM1 in 1 BLISTER PACKLIPSTICK11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-494MAYBELLINE NEW YORK BABY LIPS DR RESCURE MENTHOL EXTERNAL ANALGESIC MEDICATED BALM (MENTHOL) LIPSTICK [L'OREAL USA PRODUCTS INC]1Current NDC, 2 package rows20240704_d580982f-dda6-4b03-bf84-342b9f2c6d93.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49967-49449967-494-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
OCTYLDODECANOL461N1O614YIACT
PETROLATUM4T6H12BN9UIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
DIISOSTEARYL MALATEQBS8A3XZGQIACT
SHEA BUTTERK49155WL9YIACT
CANDELILLA WAXWL0328HX19IACT
VINYLPYRROLIDONE/HEXADECENE COPOLYMERKFR5QEN0N9IACT
EUCALYPTUS OIL2R04ONI662IACT
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)255PIF62MSIACT
TOCOPHEROLR0ZB2556P8IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALUMINUM OXIDELMI26O6933IACT
LIMONENE, (+)-GFD7C86Q1WIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
CALCIUM SODIUM BOROSILICATE4MM76N4WMYIACT
CALCIUM ALUMINUM BOROSILICATE3JRB8A35M0IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
HONEYY9H1V576FHIACT
CENTELLA ASIATICA TRITERPENOIDS4YS74Q4G4JIACT
DIMETHICONE92RU3N3Y1OIACT
STANNIC OXIDEKM7N50LOS6IACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FERRIC OXIDE RED1K09F3G675IACT
D&C RED NO. 7ECW0LZ41X8IACT
MICAV8A1AW0880IACT
FD&C YELLOW NO. 6 ALUMINUM LAKEGYP6Z2JR6QIACT
FD&C BLUE NO. 1 ALUMINUM LAKEJ9EQA3S2JMIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Maybelline New York BABY LIPS DR RESCURE MENTHOL EXTERNAL ANALGESIC MEDICATED BALMMENTHOLL'Oreal USA Products Incd580982f-dda6-4b03-bf84-342b9f2c6d932024-06-29WarningsExact identifier
ndc (package): 49967-494-01
ndc (product): 49967-494
ndc11 (package): 49967049401
spl id: 611ae21f-a874-492d-9ffe-4be59e8629b5
spl set id: d580982f-dda6-4b03-bf84-342b9f2c6d93

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.