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| Product NDC Code | 70983-021 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Sweet cheeks |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | OINTMENT | ||||||
| RxCUI drug identifier | 199852 | ||||||
| Application Number | M016 | ||||||
| Labeler Name | Saje Natural Business 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 12%
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.Principal display panel information daily diaper rash ointment net wt. 75g (2.7 oz) and net wt. 30g (1oz) daily diaper rash ointment
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 Olive oil, beeswax (yellow), butyrospermum parkii (shea) butter, coconut oil, castor oil, aloe barbadensis leaf extract, glycerin, vitamin e, calendula officinalis flower extract, hypericum perforatum flower extract (st john's wort), sunflower oil, rosmarinus officinalis (rosemary) leaf extract, echinacea angustifolia extract, camellia sinensis leaf extract (green tea), althaea officinalis root (marshmallow root), daucus carota sativa (carrot) seed oil, lavender 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 or minor skin irritations due to diaper rash. seals 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.Sweet cheeks Zinc oxide SHEA BUTTER COCONUT OIL YELLOW WAX CASTOR OIL SUNFLOWER OIL TOCOPHEROL HYPERICUM PERFORATUM FLOWER LAVENDER OIL ALOE VERA LEAF GLYCERIN OLIVE OIL ZINC OXIDE ZINC OXIDE CALENDULA OFFICINALIS FLOWER ROSEMARY ECHINACEA ANGUSTIFOLIA GREEN TEA LEAF ALTHAEA OFFICINALIS ROOT CARROT SEED 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.Sweet cheeks daily diaper rash ointment-Outer label Sweet Cheeks 1oz drug facts Sweet cheeks box 75g
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.Warnings -Do not use if allergic to plants of the marshmallow or asteraceae/compositae/daisy family.
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.Warnings -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.Warnings -Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 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.Warnings -When using this product, avoid contact with the eyes and mucous membranes.
References
This field may contain references when prescription drug labeling must summarize or otherwise relay on a recommendation by an authoritative scientific body, or on a standardized methodology, scale, or technique, because the information is important to prescribing decisions.Questions? 1-877-275-7253
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.Warnings Warnings -Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days. Warnings -Do not use if allergic to plants of the marshmallow or asteraceae/compositae/daisy family. Warnings -When using this product, avoid contact with the eyes and mucous membranes. Warnings -Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
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