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| Product NDC Code | 26052-028 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Burts bees baby bee diaper rash |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | OINTMENT | ||||||
| RxCUI drug identifier | 244638 | ||||||
| Application Number | part347 | ||||||
| Labeler Name | BURT'S BEES, INC. | ||||||
| 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 Zinc Oxide 40%
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 AND 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 ANYTIME WHEN EXPOSURE TO WET DIAPERS MAY BE PROLONGED.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL, BEESWAX, LANOLIN, RICINUS COMMUNIS (CASTOR) SEED OIL, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, BUTYROSPERMUM PARKII (SHEA) BUTTER, GLYCERYL ROSINATE, OLEA EUROPAEA (OLIVE) FRUIT OIL, HYDROGENATED CASTOR OIL, OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES, ANTHEMIS NOBILIS FLOWER OIL, LAVANDULA ANGUSTIFOLIA (LAVENDER) FLOWER, LAVANDULA HYBRIDA OIL, CALENDULA OFFICINALIS FLOWER EXTRACT, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT, TOCOPHEROL, GLYCINE SOJA (SOYBEAN) OIL, CANOLA OIL
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.Purpose Skin Protectant
Spl product data elements
Usually a list of ingredients in a drug product.BURTS BEES BABY BEE DIAPER RASH ZINC OXIDE SHEA BUTTER CASTOR OIL JOJOBA OIL OLIVE OIL HYDROGENATED CASTOR OIL CHAMAEMELUM NOBILE FLOWER OIL LAVANDULA ANGUSTIFOLIA FLOWER TOCOPHEROL CALENDULA OFFICINALIS FLOWER SOYBEAN OIL CANOLA OIL ROSEMARY LAVANDIN OIL ZINC OXIDE ZINC OXIDE ALMOND OIL YELLOW WAX LANOLIN
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.MAXIMUM STRENGTH - 40% ZINC OXIDE BURT'S BEES BABY BEE DIAPER RASH OINTMENT HELPS TREAT & PREVENT DIAPER RASH 100% NATURAL NET WT. 3 oz. / 85 g Baby Bee Diaper Ointment
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 product is 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 worstened or does not improve after 7 days
Storage and handling
Information about safe storage and handling of the drug product.OTHER INFORMATION STORE AT ROOM TEMPERATURE
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 keep out of eyes.
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