OKEEFFES MEDICATED LIP REPAIR SEAL AND HEAL- medicated lip repair stick 
Raining Rose, Inc.

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O'Keeffe's Medicated Lip Repair

Drug Facts

Active Ingredient: Petrolatum 30%

Purpose

Lip protectant

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

Warnings

For external use only

When using this product do not get into eyes

Stop use and ask doctor if • condition worsens

• 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.

Directions apply as needed

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

​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

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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OKEEFFES MEDICATED LIP REPAIR SEAL AND HEAL 
medicated lip repair stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65692-0309
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM1.26 g  in 4.2 g
Inactive Ingredients
Ingredient NameStrength
WHITE WAX (UNII: 7G1J5DA97F)  
SHEA BUTTER (UNII: K49155WL9Y)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
HYDROGENATED POLY(C6-14 OLEFIN; 2 CST) (UNII: P0TX083987)  
ALMOND OIL (UNII: 66YXD4DKO9)  
CHIA SEED OIL (UNII: MC2LH51BO7)  
TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S) (UNII: 587WKM3S9Q)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
METHYL NICOTINATE (UNII: 7B1AVU9DJN)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65692-0309-11 in 1 BLISTER PACK03/01/2022
14.2 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02003/01/2022
OKEEFFES MEDICATED LIP REPAIR SEAL AND HEAL 
medicated lip repair stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65692-0310
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM1.26 g  in 4.2 g
Inactive Ingredients
Ingredient NameStrength
WHITE WAX (UNII: 7G1J5DA97F)  
SHEA BUTTER (UNII: K49155WL9Y)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
HYDROGENATED POLY(C6-14 OLEFIN; 2 CST) (UNII: P0TX083987)  
ALMOND OIL (UNII: 66YXD4DKO9)  
CHIA SEED OIL (UNII: MC2LH51BO7)  
TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S) (UNII: 587WKM3S9Q)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
METHYL NICOTINATE (UNII: 7B1AVU9DJN)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65692-0310-12 in 1 BLISTER PACK03/01/2022
14.2 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02003/01/2022
Labeler - Raining Rose, Inc. (083819404)
Registrant - Raining Rose, Inc. (083819404)

Revised: 11/2023
Document Id: 31e65ac9-28f7-42a2-b757-3663ce8be477
Set id: dda5b7f0-af6a-4bb0-b68b-46512db4a366
Version: 2
Effective Time: 20231103
 
Raining Rose, Inc.