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| Product NDC Code | 71564-005 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Okeeffes lip repair seal and heal |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | STICK | ||||||
| Application Number | part347 | ||||||
| Labeler Name | The Gorilla Glue Company/O'Keeffe's Company | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Petrolatum 30%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions apply as needed
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.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
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses Helps prevent and temporarily protects chapped or cracked lips Helps prevent and protect from the drying effects of wind and cold weather
Purpose
Information about the drug product’s indications for use.Purpose Lip protectant
Spl product data elements
Usually a list of ingredients in a drug product.OKEEFFES LIP REPAIR SEAL AND HEAL Petrolatum PETROLATUM PETROLATUM HYDROGENATED POLY(C6-14 OLEFIN; 2 CST) CHIA SEED OIL SACCHARIN SODIUM YELLOW WAX SHEA BUTTER DIMETHICONE DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) ALMOND OIL TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S) BERGAMOT OIL PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.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 SINGLE
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
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
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 1-800-275-2718
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.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.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product do not get into eyes.
Storage and handling
Information about safe storage and handling of the drug product.Other information Protect this product from excessive heat and direct sun
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API