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Product NDC Code | 69968-0692 | ||||
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Drug Name | Aveeno baby bathtime solutions mommy and me gift set |
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Type | Brand | ||||
Dosage Form | KIT | ||||
Application Number | M016 | ||||
Labeler Name | Kenvue Brands LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Dimethicone 1.2%
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 Apply as needed.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water, Glycerin, Distearyldimonium Chloride, Petrolatum, Isopropyl Palmitate, Cetyl Alcohol, Avena Sativa (Oat) Kernel Flour, Benzyl Alcohol, Sodium Chloride, Allantoin
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 prevent and temporarily protects chafed, chapped or cracked skin
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.Aveeno Baby Bathtime Solutions Mommy and Me Gift Set Dimethicone Aveeno Baby Daily Moisture Dimethicone WATER GLYCERIN DISTEARYLDIMONIUM CHLORIDE PETROLATUM ISOPROPYL PALMITATE CETYL ALCOHOL OAT BENZYL ALCOHOL SODIUM CHLORIDE ALLANTOIN DIMETHICONE DIMETHICONE Aveeno Baby Daily Moisture Wash and Shampoo WATER COCAMIDOPROPYL BETAINE SODIUM LAUROAMPHOACETATE GLYCERIN COCO GLUCOSIDE SODIUM CHLORIDE CITRIC ACID MONOHYDRATE CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) SODIUM BENZOATE GLYCERYL OLEATE SODIUM HYDROXIDE GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) OAT Aveeno Baby Calming Comfort Bath SODIUM CHLORIDE CITRIC ACID MONOHYDRATE CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) SODIUM BENZOATE GLYCERYL OLEATE POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) SODIUM HYDROXIDE OAT WATER COCAMIDOPROPYL BETAINE SODIUM LAUROAMPHOACETATE GLYCERIN COCO GLUCOSIDE Aveeno Stress Relief Body Wash WATER GLYCERIN COCAMIDOPROPYL BETAINE SODIUM LAURETH-3 SULFATE OATMEAL CITRIC ACID MONOHYDRATE SODIUM CHLORIDE SODIUM BENZOATE GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) GLYCOL DISTEARATE EDETATE SODIUM MYRISTYL ALCOHOL SODIUM HYDROXIDE
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 - Kit Container RECOMMENDED BY PEDIATRICIANS & DERMATOLOGISTS Aveeno ® baby bathtime solutions mommy & me gift set for BABY: Daily Moisture Wash & Shampoo 8 fl oz (236 mL), Daily Moisture Lotion 8 oz (227 g), CALMING COMFORT ® Bath 8 fl oz (236mL) for MOM: Stress Relief Body Wash 12 fl oz (354 mL) PRINCIPAL DISPLAY PANEL - Kit Container
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
Distributed by: JOHNSON & JOHNSON CONSUMER INC. Skillman, NJ 08558
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.Do not use on Deep or puncture wounds Animal bites Serious burns
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 866-428-3366; Outside US dial collect 215-273-8755 www.aveeno.com
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 To open, twist off cap and remove quality seal. Do not use if quality seal is broken. 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 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 Do not use on Deep or puncture wounds Animal bites Serious burns 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