Maybelline New York Baby Lips Dr Rescue Medicated Balm

Manufacturer
L'Oreal USA Products Inc | L'Oreal USA, Inc.
Effective date
2023-12-28
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:05:53

Label at a glance#

ProductMaybelline New York Baby Lips Dr Rescue Medicated Balm
Active ingredientMENTHOL
Label structure11 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

Inactive ingredients

INACTIVE INGREDIENT SECTION

octyldodecanol, polybutene, petrolatum, isopropyl myristate, polyethylene, ozokerite, diisostearyl malate, butyrospermum parkii (shea) butter, euphorbia cerifera (candelilla) wax, VP/hexadecene copolymer, eucalyptus globulus leaf oil, penaerythrityl tetra-di-t-butyl hydroxyhydrocinamate, tocopherol, tocopheryl acetate, limonene, honey, centella asiatica extract

Questions or comments?

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-489-01Maybelline New York Baby Lips Dr Rescue Medicated Balm1 in 1 BLISTER PACKLIPSTICK13
49967-489-01Maybelline New York Baby Lips Dr Rescue Medicated Balm4.4 g in 1 TUBELIPSTICK4.43

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-489MAYBELLINE NEW YORK BABY LIPS DR RESCUE MEDICATED BALM (MENTHOL) LIPSTICK [L'OREAL USA PRODUCTS INC]3Current NDC, Legacy NDC, 2 package rows20231229_2f7b8221-66f6-4aed-8359-318cfc656a72.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3A1
MENTHOLACTIVE MOIETYL7T10EIP3A1

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49967-48949967-489-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

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 Rescue Medicated BalmMENTHOLL'Oreal USA Products Inc2f7b8221-66f6-4aed-8359-318cfc656a722023-12-28WarningsExact identifier
ndc (package): 49967-489-01
ndc (product): 49967-489
ndc11 (package): 49967048901
spl id: ba1a3de6-6343-48d2-973e-83598d78c17c
spl set id: 2f7b8221-66f6-4aed-8359-318cfc656a72

Reported adverse events (FAERS/openFDA)#

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