FDA.reportPublic FDA data

O'KEEFFE'S LIP REPAIR SEAL & HEAL

Manufacturer
The Gorilla Glue Company/O'Keeffe's Company
Effective date
2026-07-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-07-29 05:10:13

Label at a glance#

ProductOKeeffes Lip Repair SEAL and HEAL
Active ingredientPETROLATUM
Label structure11 sections

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

.

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

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

  • 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 information

SPL UNCLASSIFIED SECTION

Protect this product from excessive heat and direct sun

INACTIVE INGREDIENT SECTION

Inactive ingredients Beeswax, ButyrospermumParkii (Shea) Butter, Prunus Amygdalus Dulcis (SweetAlmond) Oil, Dimethicone, Hydrogenated Poly (C6-14Olefin), Trimethylpentanediol /Adipic Acid/GlycerinCrosspolymer, Polysilicone-11, Menthyl Nicotinate,Ethylene/Propylene/Styrene Copolymer, Flavor, PunicaGranatum (Pomegranate) Seed Oil, Sodium Saccharin,Butylene/Ethylene/Styrene Copolymer, PentaerythritylTetra-di-t-butyl Hydroxyhydrocinnamate

OTC - QUESTIONS SECTION

Questions or comments? 1-800-275-2718

SPL UNCLASSIFIED SECTION

HYPOALLERGENIC • ABSORBS QUICKLY• 8-HOUR HYDRATION

Guarantee: If you are not fully satisfied, we will refund 100% of the purchase price. Please retain product and call 1-800-274-2718 for replacement product or refund.

©2026 Distributed by: O'Keeffe's Company

Cincinnati, OH 45241

Made in USA with Domestic and

Imported Materials

www.OKeeffesCompany.com

Questions/Comments: 1-800-275-2718

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

O'KEEFFE'S LIP REPAIR

SEAL & HEAL

MEDICATED

LIP PROTECTANT

INSTANT RELIEF

FOR DRY CRACKS & SPLITS

SEALS & HEALS

DRY CRACKS & SPLITS

ALL DAY PROTECTION IN ONE USE

MATTE FINISH • GUARANTEED RELIEF

2 STICKS Net Wt. 0.15 oz. (4.2 g) each, Total Net Wt. 0.3 oz (8.4g)

labellabel

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71564-01171564-011-22

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
PETROLATUM4T6H12BN9UACTIB
MENTHYL NICOTINATE, (-)-2PXE57RY69IACT
DIMETHICONE92RU3N3Y1OIACT
WHITE WAX7G1J5DA97FIACT
PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL66YXD4DKO9IACT
SACCHARIN SODIUM ANHYDROUSI4807BK602IACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
HYDROGENATED POLYDECENE (1500 CST)4YI0729529IACT
BUTYROSPERMUM PARKII (SHEA) BUTTERK49155WL9YIACT
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)255PIF62MSIACT
STYRENE/ISOPRENE COPOLYMER (28:72; 210000 MW)H58HX2GWJ5IACT
ADIPIC ACID/DIGLYCOL CROSSPOLYMER (20000 MPA.S)R9TPS68K19IACT
PUNICA GRANATUM SEED OIL0UI45XV0T6IACT

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
OKeeffes Lip Repair SEAL and HEALPETROLATUMThe Gorilla Glue Company/O'Keeffe's Company55f66f54-da39-76c7-e063-6394a90aeda92026-07-27WarningsExact identifier
ndc (package): 71564-011-22
ndc (product): 71564-011
ndc11 (package): 71564001122
spl id: 57992992-a82d-3748-e063-6294a90a14a7
spl set id: 55f66f54-da39-76c7-e063-6394a90aeda9

Reported adverse events (FAERS/openFDA)#

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