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|Product NDC Code||69968-0541|
Aveeno baby eczema therapy soothing bath treatment
|Pharm Class||Allergens [CS],
Cell-mediated Immunity [PE],
Dietary Proteins [CS],
Grain Proteins [EXT],
Increased Histamine Release [PE],
Non-Standardized Food Allergenic Extract [EPC],
Non-Standardized Plant Allergenic Extract [EPC],
Plant Proteins [CS]
|Labeler Name||Johnson & Johnson Consumer Inc.|
Active ingredientA list of the active, medicinal ingredients in the drug product.
Active ingredient Colloidal oatmeal 43%
Dosage and administrationInformation 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 For dispersal in water: Turn warm water faucet on to full force. Slowly sprinkle packet of colloidal oatmeal directly under the faucet into the tub or container. Stir any colloidal oatmeal settled on the bottom. For use as a soak in a bath: Slowly sprinkle one packet in an infant tub filled with warm water. Stir any colloidal oatmeal that may have settled on the bottom. Soak affected area for 15 to 30 minutes as needed, or as directed by a doctor. Pat dry (do not rub) to keep a thin layer on the skin.
Inactive ingredientA list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients Mineral Oil, Calcium Silicate, Laureth-4
Indications and usageA 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 Temporarily protects and helps relieve minor skin irritation and itching due to: Rashes Eczema Poison ivy, oak or sumac Insect bites
PurposeInformation about the drug product’s indications for use.
Purpose Skin protectant
Spl product data elementsUsually a list of ingredients in a drug product.
Aveeno Baby Eczema Therapy Soothing Bath Treatment Oatmeal MINERAL OIL CALCIUM SILICATE LAURETH-4 OATMEAL OATMEAL
Package label principal display panelThe 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 - 213 g Packet Carton RECOMMENDED BY PEDIATRICIANS & DERMATOLOGISTS Aveeno ® baby NEW LOOK Same Great Formula eczema therapy soothing bath treatment colloidal oatmeal skin protectant relieves dry, itchy, irritated skin due to: eczema, rashes, poison ivy/oak/sumac, insect bites fragrance-free, allergy tested, tear-free, steroid free ACCEPTED NATIONALECZEMA.ORG National Eczema Association 10 Bath Packets TOTAL NET WT. 7.5 OZ. (213 g) PRINCIPAL DISPLAY PANEL - 213 g Packet Carton
Spl unclassified sectionInformation 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
Keep out of reach of childrenInformation 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.
QuestionsA 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 useInformation 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 usingInformation 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. To avoid slipping, use mat in tub or shower. In some skin conditions, soaking too long may overdry.
Storage and handlingInformation about safe storage and handling of the drug product.
Other information Store at room temperature.
WarningsInformation 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. To avoid slipping, use mat in tub or shower. In some skin conditions, soaking too long may overdry. 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 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