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| Product NDC Code | 59062-1219 | ||||
|---|---|---|---|---|---|
| Drug Name | Babyganics diaper rash |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 245660 | ||||
| Application Number | part347 | ||||
| Labeler Name | KAS Direct LLC dba BabyGanics | ||||
| 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 15%
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 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.Inactive ingredients water, butyrospermum parkii (shea) butter, theobroma cacao (cocoa) seed butter, prunus amygdalus dulcis (sweet almond) oil, glycol stearate, simmondsia chinensis (jojoba) seed oil, polyglyceryl-3 polyricinoleate, glycerin, tocopheryl acetate, solanum lycopersicum (tomato) seed oil, helianthus annuus (sunflower) seed oil, vaccinium macrocarpon (cranberry) seed oil, nigella sativa (black cumin) seed oil, rubus idaeus (red raspberry) seed oil, calendula officinalis flower extract, aloe barbadensis leaf juice, sorbitan sesquioleate, cetyl ricinoleate, glyceryl caprate, beeswax, sodium polyacryloyldimethyl taurate, hydroxyethylcellulose, hydrogenated polydecene, trideceth-10, butylene glycol, magnesium stearate, aluminum tristearate, sodium benzoate, gluconolactone
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 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.BABYGANICS DIAPER RASH ZINC OXIDE ZINC OXIDE ZINC OXIDE WATER SHEANUT OIL GLYCOL STEARATE JOJOBA OIL POLYGLYCERYL-3 RICINOLEATE GLYCERIN .ALPHA.-TOCOPHEROL ACETATE TOMATO SEED OIL SUNFLOWER OIL CRANBERRY SEED OIL NIGELLA SATIVA SEED OIL RASPBERRY SEED OIL CALENDULA OFFICINALIS FLOWER ALOE VERA LEAF SORBITAN SESQUIOLEATE CETYL RICINOLEATE GLYCERYL CAPRATE YELLOW WAX SODIUM TAURATE HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) HYDROGENATED POLYDECENE (550 MW) TRIDECETH-10 BUTYLENE GLYCOL MAGNESIUM STEARATE ALUMINUM STEARATE SODIUM BENZOATE GLUCONOLACTONE
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 treats & protects babyganics ® diaper rash cream with zinc oxide, calendula, aloe & jojoba ∙ helps prevent diaper rash promotes healing ∙ non allergenic pediatrician & dermatologist tested no: parabens, phthalates, petroleum, mineral oil, dyes or fragrances + NeoNourish ® Natural Seed Oil Blend 4 OZ (113g) 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
Dist. by: KAS Direct, LLC. Hicksville, NY 11801
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 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 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
Storage and handling
Information about safe storage and handling of the drug product.Other information Store at room temperature 59-77°F (15-25°C)
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 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