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| Product NDC Code | 69968-0755 | ||||
|---|---|---|---|---|---|
| Drug Name | Aveeno calm plus restore skin therapy balm |
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| Type | Brand | ||||
| 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] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 240651 | ||||
| Application Number | M016 | ||||
| Labeler Name | Kenvue Brands LLC | ||||
| 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 Colloidal Oatmeal 1%
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, Panthenol, Distearyldimonium Chloride, Petrolatum, Isopropyl Palmitate, Cetyl Alcohol, Caprylic/Capric Triglyceride, Avena Sativa (Oat) Kernel Oil, Steareth-20, Benzalkonium Chloride, Ceramide NP, Avena Sativa (Oat) Kernel Extract, Sodium Chloride
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 Temporarily protects and helps relieve minor skin irritation and itching due to: rashes eczema poison ivy, oak, or sumac insect bites
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 Calm Plus Restore Skin Therapy Balm Colloidal Oatmeal BENZALKONIUM CHLORIDE OATMEAL OATMEAL SODIUM CHLORIDE PANTHENOL ISOPROPYL PALMITATE STEARETH-20 OAT KERNEL OIL CERAMIDE NP MEDIUM-CHAIN TRIGLYCERIDES OAT WATER GLYCERIN DISTEARYLDIMONIUM CHLORIDE DISTEARYLDIMONIUM PETROLATUM CETYL ALCOHOL
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 - 48g Tube Carton NEW! Aveeno® Calm + Restore SKIN THERAPY BALM Colloidal Oatmeal Skin Protectant Sensitive Skin Soothes and deeply moisturizes to help strengthen skin’s natural moisture barrier STEROID FREE FRAGRANCE-FREE DERMATOLOGIST RECOMMENDED BRAND COLLOIDAL OATMEAL + CERAMIDE net wt. 1.7 oz (48 g) Aveeno_001
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
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 Do not use if quality seal is broken or missing. 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 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