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| Product NDC Code | 57337-060 | ||||
|---|---|---|---|---|---|
| Drug Name | Xtracare creamy petroleum jelly |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | JELLY | ||||
| RxCUI drug identifier | 1037285 | ||||
| Application Number | part347 | ||||
| Labeler Name | Rejoice International | ||||
| 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: Purpose Petrolatum 30% ................................ Skin Protectant
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: water, carbomer, stearic acid, mineral oil, cetyl alcohol, glycerin, ceteareth-20, glyceryl monostearate, methylparaben, propylparaben, DMDM hydantoin, triethanolamine, disodium EDTA, theobroma cacao (cocoa) seed butter, fragrance, FD&C yellow no.5, FD&C red no.40, D&C red no.33.
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.XtraCare® Creamy Petroleum Jelly Cocoa Butter enriched Skin Protector Dry Skin Relief Rich Creamy Moisturiser *Compare to the active ingredient in Vaseline® Petroleum Jelly Cream Net Wt 4.5oz (127g) Xtracare® XtraCare Creamy Petroleum Jelly is specially formulated to moisturize, soften and soothe dry skin. Blended with Coco butter oil to product a rich creamy moisturizer. Use on hands, knees, feet and heels to smooth away dryness. Great for moisturizing face and neck.
Purpose
Information about the drug product’s indications for use.Uses temporarily protects minor: cuts, scrapes, burns temporarily protects and helps relieve chapped or cracked skin helps protect from the drying effects of wind and cold weather
Spl product data elements
Usually a list of ingredients in a drug product.XtraCare Creamy Petroleum Jelly Petrolatum WATER CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) STEARIC ACID MINERAL OIL CETYL ALCOHOL GLYCERIN POLYOXYL 20 CETOSTEARYL ETHER GLYCERYL MONOSTEARATE METHYLPARABEN PROPYLPARABEN DMDM HYDANTOIN TROLAMINE EDETATE SODIUM COCOA BUTTER FD&C YELLOW NO. 5 FD&C RED NO. 40 D&C RED NO. 33 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.label image
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information store at room temperature. Questions/Comments? 1-855-345-5575 *this product is nor manufactured or distributed by UNILEVER, distributor of the registered trademark Vaseline®. DISTRIBUTED BY REJOICE INTERNATIONAL INC NORTHVILLE, MI 48168 USA MADE IN CHINA
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 condition worsens symptoms last more than 7 days or clear up and occur again within a few days Do not use on deep puncture wounds animal bites serious burns
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