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| Product NDC Code | 52412-450 | ||||
|---|---|---|---|---|---|
| Drug Name | Balmex multi-purpose |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | OINTMENT | ||||
| RxCUI drug identifier | 1492066, 1492071 |
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| Application Number | part347 | ||||
| Labeler Name | Randob Labs,Ltd. | ||||
| 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 Purpose Petrolatum 51.1% Skin protectant
| | |
| | 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 change wet or soiled diapers promptly, cleanse the diaper area, and allow to dry apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients acacia farnesiana flower extract, allantoin, aloe barbadenis leaf extract, chamomilla recutita (matricaria) flower extract, cholecalciferol, cyclomethicone, dimethicone, fragrance, isopropyl myristate, isopropyl palmitate, lavandula angustifolia (lavender) extract, mineral oil, polyethylene, retinyl palmitate, rosmarinus officinalis (rosemary) extract, silica, tocopheryl acetate, zea mays (corn) oil (245-276)
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 burns temporarily protects and helps relieve chapped or cracked skin helps treat and prevent diaper rash protects chafed skin due to diaper rash and helps seal out wetness
Purpose
Information about the drug product’s indications for use.Active ingredients Purpose Petrolatum 51.1% Skin protectant
| | |
| | Skin protectant |
Spl product data elements
Usually a list of ingredients in a drug product.BALMEX MULTI-PURPOSE Petrolatum Petrolatum Petrolatum Vachellia Farnesiana Flower Allantoin Aloe Vera Leaf Chamomile Cholecalciferol Cyclomethicone 5 Cyclomethicone 6 Dimethicone 200 Isopropyl Myristate Isopropyl Palmitate Lavandula Angustifolia Subsp. Angustifolia Flowering Top Mineral Oil High Density Polyethylene Vitamin A Palmitate Rosemary Silicon Dioxide .alpha.-tocopherol Acetate, Dl- Corn Oil
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.PRINCIPAL DISPLAY PANEL - 99 g Tube Label NEW LOOK-SAME PRODUCT Balmex® MULTI-PURPOSE HEALING OINTMENT Skin Protectant-Petrolatum 51.1% From diaper rash to chapped, chafed skin ✔ Heals, protects & soothes ✔ 7 healing moisturizers plus Vitamin A & Vitamin D ✔ Clear and easy to apply Pediatrician Recommended NET WT 3.5 OZ (99 g) Principal Display Panel - 99 g Tube Label
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
Other information do not use if quality seal is broken see bottom of tube for lot number and expiration date
Distributed by RANDOB LABS LTD. Box 440, Cornwall, NY 12518
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 immediately.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-833-389-9450
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 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 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 or puncture wounds animal bites serious burns Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
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