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| Product NDC Code | 53329-303 | ||||
|---|---|---|---|---|---|
| Drug Name | Soothe and cool moisture guard |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | PASTE | ||||
| RxCUI drug identifier | 1543744 | ||||
| Application Number | M016 | ||||
| Labeler Name | Medline Industries, LP | ||||
| 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 59%
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 gently cleanse and dry affected area Apply as needed
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Aloe Barbadensis Leaf Juice, Aluminum Stearates, Beeswax, Benzethonium Chloride, Chloroxylenol, Cholecalciferol, Dicocoyl Pentaerythrityl Distearyl Citrate, Fragrance, Mineral Oil, Paraffin, Phenoxyethanol, Retinyl Palmitate, Sorbitan Sesquioleate, Stearic Acid, Tocopherol, Water, Zea Mays (Corn) Oil, Zinc Oxide
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 Temporarily protects minor cuts, scrapes, and burns Temporarily protects and helps relieve chapped or cracked skin Protects minor skin irritation associated with diaper rash and helps seal out wetness
Purpose
Information about the drug product’s indications for use.Purpose Skin Protectant
Spl product data elements
Usually a list of ingredients in a drug product.Soothe and Cool Moisture Guard White Petrolatum ALOE VERA LEAF ALUMINUM STEARATES YELLOW WAX BENZETHONIUM CHLORIDE CHLOROXYLENOL CHOLECALCIFEROL PENTAERYTHRITYL DISTEARATE MINERAL OIL PARAFFIN PHENOXYETHANOL VITAMIN A PALMITATE SORBITAN SESQUIOLEATE STEARIC ACID TOCOPHEROL WATER CORN OIL ZINC OXIDE 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.Package Label Label 303
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.REF MSC954435 www.medline.com Manufactured for Medline Industries, Inc. Mundelein, IL 60060 USA. 1-800-MEDLINE RL15UPK
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use on deep or puncture wounds animal bites serious burns
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.
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 condition worsens symptoms last for 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
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. Do not use on deep or puncture wounds animal bites serious burns When using this product do not get into eyes Stop use and ask a doctor if condition worsens symptoms last for 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