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| Product NDC Code | 52412-285 | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | M016 | ||||||||||||
| 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.Zinc Oxide 11.3%
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.Change wet and 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 anytime when exposure to wet diapers may be prolonged.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Beeswax, benzoic acid, dimethicone, glycine soja (soybean) oil, magnesium aspartate, microcrystalline wax, mineral oil, oenothera biennis (evening primrose) seed extract, olea europae (olive) leaf extract, panthenol, Peruvian balsam, Phenoxyethanol, potassium aspartate, potassium hydroxide, sarcosine, sodium cocoyl amino acids, sorbitan sesquioleate, synthetic beeswax, tocopherol, water.
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.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.Skin Protectant
Spl product data elements
Usually a list of ingredients in a drug product.Balmex Diaper Rash Zinc Oxide 11.3% BENZOIC ACID DIMETHICONE 350 SOYBEAN OIL MAGNESIUM ASPARTATE MICROCRYSTALLINE WAX MINERAL OIL EVENING PRIMROSE OIL OLEA EUROPAEA LEAF PANTHENOL BALSAM PERU PHENOXYETHANOL POTASSIUM ASPARTATE ZINC OXIDE ZINC OXIDE POTASSIUM HYDROXIDE SARCOSINE COCO ACID CHLORIDES SORBITAN SESQUIOLEATE SYNTHETIC BEESWAX TOCOPHEROL WATER YELLOW 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.Label
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.If swallowed, seek medical help or contact a Poison Control Center immediately.
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.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.
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