OKeeffes Medicated Lip Repair Seal and Heal

Manufacturer
Raining Rose, Inc.
Effective date
2023-11-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:22:25

Label at a glance#

ProductOKeeffes Medicated Lip Repair Seal and Heal
Active ingredientPETROLATUM
Label structure9 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Petrolatum 30%

OTC - PURPOSE SECTION

Purpose

Lip protectant

INDICATIONS & USAGE SECTION

Uses
• Helps prevent and temporarily protects chapped or cracked lips.
• Helps prevent and protect from the drying effects of wind and cold weather

WARNINGS SECTION

Warnings

For external use only

When using this product do not get into eyes

OTC - STOP USE SECTION

Stop use and ask doctor if • condition worsens

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

• Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions apply as needed

OTHER SAFETY INFORMATION

Other Information ​​Protect this product from excessive heat and direct sun

INACTIVE INGREDIENT SECTION

​INACTIVE INGREDIENTS: Beeswax, Butyrospermum ParkII (Shea) Butter, Dimethicone,

Hydrogenated Poly (C6-14 Olefin), Prunus Amygdalus Dulcis (Sweet Almond) Oil, Salvia

Hispanica (Chia) Seed Oil, Trimethylpentanediol/Adipic Acid/Glyerin Crosspolymer,

Polysilicone-11, Menthyl Nicotinate, Citrus Aurantium Bergamia (Bergamot) Fruit Oil,

Ethylene/Propylene/Styrene, Copolymer, Sodium Saccharin, Butylene/Ethylene/Styrene

Copolymer, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate

Principal Display Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

O'KEEFFE'S MEDICATED LIP REPAIR SEAL & HEAL

Distributed by O'Keeffe's Company, Cincinnati, OH 45241

Questions/Comments: 1-800-275-2718

Lip Repair

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1-Stick Package

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2-Stick Package

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Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65692-030965692-0309-1
65692-031065692-0310-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 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
31e65ac9-28f7-42a2-b757-3663ce8be477dda5b7f0-af6a-4bb0-b68b-46512db4a3662023-11-03WarningsExact identifier
spl id: 31e65ac9-28f7-42a2-b757-3663ce8be477
spl set id: dda5b7f0-af6a-4bb0-b68b-46512db4a366

Reported adverse events (FAERS/openFDA)#

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