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| Product NDC Code | 52412-400 | ||||||||||
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| Drug Name | Balmex diaper 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 change wet or soiled diapers promptly, cleanse the diaper area, and allow to dry apply cream 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 Beeswax, benzoic acid, dimethicone, fragrance, glycine soja (soybean) oil, magnesium aspartate, methylparaben, microcrystalline wax, mineral oil, oenothera biennis (evening primrose) seed extract, olea europea (olive) leaf extract, panthenol, potassium aspartate, potassium hydroxide, propylparaben, sarcosine, sodium cocoyl amino acids, sorbitan sesquioleate, synthetic beeswax, tocopherol, water (245-230)
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 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 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 Diaper Rash Zinc Oxide Zinc Oxide Zinc Oxide Yellow Wax Benzoic Acid Dimethicone 100 Soybean Oil Magnesium Aspartate Anhydrous Methylparaben Microcrystalline Wax Mineral Oil Oenothera Biennis Olea Europaea Leaf Dexpanthenol Potassium Aspartate Potassium Hydroxide Propylene Glycol Propylparaben Sarcosine Sorbitan Sesquioleate Tocopherol Water Sodium Cocoyl Glycinate 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 - 113 g Tube Carton NEW LOOK-SAME PRODUCT Balmex® COMPLETE PROTECTION™ Zinc Oxide DIAPER RASH CREAM Prevents & Heals ✔ Protects against all 3 leading causes of diaper rash ✔ Reduces rash in just 1 diaper change Pediatrician Recommended Advanced Formula NET WT 4 OZ (113 g) PRINCIPAL DISPLAY PANEL - 113 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
Other information do not use if quality seal is broken see bottom of carton and or top of tube for lot number and expiration date
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 Dist. by: RANDOB LABS LTD. Box 440, Cornwall, NY 12518
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. 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