OKEEFFES LIP REPAIR SEAL AND HEAL- petrolatum stick

OKEEFFES LIP REPAIR by

Drug Labeling and Warnings

OKEEFFES LIP REPAIR by is a Otc medication manufactured, distributed, or labeled by The Gorilla Glue Company/O'Keeffe's Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Petrolatum 30%

PURPOSE

Purpose

Lip protectant

INDICATIONS & USAGE

Uses

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

WARNINGS

Warnings

For external use only

When using this product do not get into eyes.

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.

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

DOSAGE & ADMINISTRATION

Directions apply as needed

STORAGE AND HANDLING

Other information

Protect this product from excessive heat and direct sun

INACTIVE INGREDIENT

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

QUESTIONS

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

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)

INGREDIENTS AND APPEARANCE

OKEEFFES LIP REPAIR  SEAL AND HEAL
petrolatum stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71564-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	30 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
HYDROGENATED POLY(C6-14 OLEFIN; 2 CST) (UNII: P0TX083987)
CHIA SEED OIL (UNII: MC2LH51BO7)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
YELLOW WAX (UNII: 2ZA36H0S2V)
SHEA BUTTER (UNII: K49155WL9Y)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
ALMOND OIL (UNII: 66YXD4DKO9)
TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S) (UNII: 587WKM3S9Q)
BERGAMOT OIL (UNII: 39W1PKE3JI)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71564-005-42	1 in 1 BLISTER PACK	08/01/2021
1		4.2 g in 1 CYLINDER; Type 0: Not a Combination Product
2	NDC: 71564-005-84	2 in 1 BLISTER PACK	08/01/2021
2		4.2 g in 1 CYLINDER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	08/01/2021

Labeler - The Gorilla Glue Company/O'Keeffe's Company (004251914)