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| Product NDC Code | 67879-307 | ||||
|---|---|---|---|---|---|
| Drug Name | Lip recovery |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | OINTMENT | ||||
| RxCUI drug identifier | 1674202 | ||||
| Application Number | M020 | ||||
| Labeler Name | PHARMAGEL INTERNATIONAL INC | ||||
| 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 INGREDIENTS PETROLATUM............................48%
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 daily to lips. Reapply as needed.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS: HYDROGENATED POLYISOBUTENE, TRIACONTANYL PVP, BUTYROSPERMUM PARKII BUTTER, PARAFFIN, SILICA, ETHYLENE/PROPYLENE/STYRENE COPOLYMER, ISOHEXA- DECANE, CYCLOPENTASILOXANE, TOCOPHEROL, SODIUM HYALURONATE, TRIPEPTIDE-1, TETRAHEXYLDECYL ASCOR- BATE, RETINYL PALMITATE, TOCOPHERYL ACETATE, ALOE BARBADENSIS (ALOE VERA) LEAF EXTRACT, COCOS NUCIFERA (COCONUT) OIL, DIMETHYLAMINOETHANOL TARTRATE, ETHYLHEXYL METHOXYCINNAMATE, BENZO- PHENONE-3, BUTYLENE/ETHYLENE/STYRENE COPOLYMER, BIS-PEG/PPG-14/14 DIMETHICONE, XANTHAN GUM, BHT, BENZYL ALCOHOL,PHENOXYETHANOL
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 PROTECT, RELIEVE, AND PREVENT CHAPPED LIPS • HELPS 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.LIP RECOVERY PETROLATUM HYDROGENATED POLYBUTENE (1300 MW) TRICONTANYL POVIDONE SHEA BUTTER PARAFFIN SILICON DIOXIDE ETHYLENE PROPYLENE STYRENE ISOHEXADECANE CYCLOMETHICONE 5 TOCOPHEROL HYALURONATE SODIUM PREZATIDE TETRAHEXYLDECYL ASCORBATE VITAMIN A PALMITATE .ALPHA.-TOCOPHEROL ACETATE ALOE VERA LEAF COCONUT OIL DEANOL BITARTRATE OCTINOXATE OXYBENZONE 1-BUTENE BIS-PEG/PPG-14/14 DIMETHICONE XANTHAN GUM BUTYLATED HYDROXYTOLUENE BENZYL ALCOHOL PHENOXYETHANOL PETROLATUM PETROLATUM
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.LR_RL-1_box_2.jpg
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 product is swallowed, get medical help or contact a Poison Control Center immediately.
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? Call 800.882.1889
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 DOCTOR IF IRRITATION OR RASH DEFELOPS AND CONTINUES FOR MORE THAN 72 HOURS.
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 WHEN USING THIS PRODUCT DO NOT GET INTO EYES. AVOID CONTACT WITH THE EYES. IF PRODUCT GETS INTO THE EYES, RINSE THOROUGHLY WITH WATER.
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