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| Product NDC Code | 52412-500 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Balmex adult care rash |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | CREAM | ||||||
| RxCUI drug identifier | 630923, 967558 |
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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 Zinc Oxide 11.3% Skin protectant
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| Zinc Oxide 11.3% | 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 gently cleanse affected skin pat dry with a clean, soft cloth or allow to air dry apply generously to affected area as needed, especially after incontinence episodes using a dry tissue to remove excess product from skin is most effective
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients mineral oil, water, beeswax, microcrystalline wax, synthetic beeswax, fragrance, sorbitan sesquioleate, oenothera biennis (evening primrose) seed extract, olea europaea (olive) leaf extract, dimethicone, tocopherol, methylparaben, glycine soja (soybean) oil, propylparaben, panthenol, sarcosine, benzoic acid, potassium aspartate, potassium hydroxide, magnesium aspartate, sodium cocoyl amino acids (309-021)
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 relieve and prevent rashes and irritation due to wetness from incontinence protects chafed skin due to irritation and helps seal out wetness
Purpose
Information about the drug product’s indications for use.Active Ingredients Purpose Zinc Oxide 11.3% Skin protectant
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|---|---|
| Zinc Oxide 11.3% | Skin protectant |
Spl product data elements
Usually a list of ingredients in a drug product.BALMEX ADULT CARE RASH Zinc Oxide Zinc Oxide Zinc Oxide Mineral Oil Water Yellow Wax Microcrystalline Wax Sorbitan Sesquioleate Oenothera Biennis Olea Europaea Leaf Dimethicone 100 Tocopherol Methylparaben Soybean Oil Propylparaben Dexpanthenol Sarcosine Benzoic Acid Potassium Aspartate Potassium Hydroxide Magnesium Aspartate Anhydrous Sodium Cocoyl Glycinate Propylene Glycol White Wax
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 - 85 g Tube Carton Activ Guard™ NEUTRALIZES IRRITANTS Balmex ® ADULTCARE ™ RASH CREAM ZINC OXIDE 11.3% Soothes & Protects Skin From Irritation, Chafing & Rash Dermatologist Tested Works in One Use* Odor-Free NET WT 3 OZ (85 g) PRINCIPAL DISPLAY PANEL - 85 g Tube Carton
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
Distributed by RANDOB LABS LTD. Box 440, Cornwall, NY 12518
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.For more information please visit www.BalmexAdult.com
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 persist 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 avoid contact with 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 avoid contact with eyes Stop use and ask a doctor if condition worsens symptoms persist 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 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