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Aveeno skin relief moisturizing fragrance free - Medication Information

Product NDC Code 69968-0408
Drug Name

Aveeno skin relief moisturizing fragrance free

Type Brand
Pharm Class Skin Barrier Activity [PE]
Active Ingredients
Dimethicone 12 mg/ml
Route TOPICAL
Dosage Form LOTION
RxCUI drug identifier 876980
Application Number M016
Labeler Name Kenvue Brands LLC
Packages
Package NDC Code Description
69968-0408-1 29 ml in 1 bottle (69968-0408-1)
69968-0408-2 354 ml in 1 bottle (69968-0408-2)
69968-0408-3 532 ml in 1 bottle (69968-0408-3)
69968-0408-4 24 bottle in 1 carton (69968-0408-4) / 29 ml in 1 bottle
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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, Avena Sativa (Oat) Kernel Oil, Steareth-20, Sodium Chloride, Butyrospermum Parkii (Shea Butter) Extract, Avena Sativa (Oat) Kernel Extract

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 helps prevent and protect from the drying effects of wind and cold weather

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 Skin Relief Moisturizing Fragrance Free Dimethicone GLYCERIN WATER DISTEARYLDIMONIUM CHLORIDE PETROLATUM ISOPROPYL PALMITATE CETYL ALCOHOL OATMEAL BENZYL ALCOHOL OAT KERNEL OIL STEARETH-20 SODIUM CHLORIDE SHEANUT DIMETHICONE DIMETHICONE OAT

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 - 532 mL Bottle Label Aveeno® Skin Relief Moisturizing LOTION Dimethicone skin protectant Helps Heal Very Dry Skin Clinically proven soothing relief for itchy, dry skin with 48-hour moisture FRAGRANCE FREE DERMATOLOGIST RECOMMENDED BRAND TRIPLE OAT & SHEA BUTTER 18 fl oz (532 mL) 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

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 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