FDA.reportPublic FDA data

OKEEFFES LIP REPAIR

Manufacturer
The Gorilla Glue Company/O'Keeffe's Company
Effective date
2023-01-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:41:13

Label at a glance#

ProductOKEEFFES LIP REPAIR SEAL AND HEAL
Active ingredientPETROLATUM
Label structure11 sections

Storage and handling

Other information Protect this product from excessive heat and direct sun

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

OTC - WHEN USING SECTION

When using this product do not get into eyes.

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • conditions worses
  • 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

STORAGE AND HANDLING SECTION

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/Glycerin 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

OTC - QUESTIONS SECTION

Questions or comments? 1-800-275-2718

SPL UNCLASSIFIED SECTION

Repairs and heals extremely dry, cracked lips

Lip Representative Photos: Two week usage period. Lip balm was applied according to package directions. Results may vary.

OKeeffesCompany.com

©2021 Distributed by:

O'Keeffe's Company

Cincinnati, OH 45241

Made in USA with Domestic and Imported Materials

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

O'KEEFFE'S

MEDICATED

LIP REPAIR

LIP PROTECTANT | PETROLATUM

+ SEAL & HEAL

RELIEVES EXTREMELY CRACKED, SPLIT LIPS

GUARANTEED RELIEF

Net Wt. 0.15 oz. (4.2 g)

106903 SEAL & HEAL SINGLE106903 SEAL & HEAL SINGLE

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71564-005-422025-02-25C16284748780-12cef2736-6461-d83d-e063-dadaa90ab31fO'Keeffe's Lip Repair Seal & Heal
71564-005-842025-02-25C16284748780-12cef2736-6461-d83d-e063-dadaa90ab31fO'Keeffe's Lip Repair Seal & Heal
71564-005-422025-01-30C16284748780-12cef2736-6461-d83d-e063-dadaa90ab31fO'Keeffe's Lip Repair Seal & Heal
71564-005-842025-01-30C16284748780-12cef2736-6461-d83d-e063-dadaa90ab31fO'Keeffe's Lip Repair Seal & Heal

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71564-00571564-005-42, 71564-005-84

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
PETROLATUM4T6H12BN9UACTIB
HYDROGENATED POLY(C6-14 OLEFIN; 2 CST)P0TX083987IACT
CHIA SEED OILMC2LH51BO7IACT
SACCHARIN SODIUMSB8ZUX40TYIACT
YELLOW WAX2ZA36H0S2VIACT
SHEA BUTTERK49155WL9YIACT
DIMETHICONE92RU3N3Y1OIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
ALMOND OIL66YXD4DKO9IACT
TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S)587WKM3S9QIACT
BERGAMOT OIL39W1PKE3JIIACT
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)255PIF62MSIACT

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
2ddef48f-7fac-1320-e063-6294a90ae2c3c68f3ba5-c0f7-dbc7-e053-2995a90a18912025-01-01WarningsExact identifier
spl set id: c68f3ba5-c0f7-dbc7-e053-2995a90a1891

Reported adverse events (FAERS/openFDA)#

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