NDC 69968-0437 Aveeno Baby Soothing Relief Moisturizing

Dimethicone

NDC Product Code 69968-0437

NDC CODE: 69968-0437

Proprietary Name: Aveeno Baby Soothing Relief Moisturizing What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Dimethicone What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used as a moisturizer to treat or prevent dry, rough, scaly, itchy skin and minor skin irritations (e.g., diaper rash, skin burns from radiation therapy). Emollients are substances that soften and moisturize the skin and decrease itching and flaking. Some products (e.g., zinc oxide, white petrolatum) are used mostly to protect the skin against irritation (e.g., from wetness). Dry skin is caused by a loss of water in the upper layer of the skin. Emollients/moisturizers work by forming an oily layer on the top of the skin that traps water in the skin. Petrolatum, lanolin, mineral oil and dimethicone are common emollients. Humectants, including glycerin, lecithin, and propylene glycol, draw water into the outer layer of skin. Many products also have ingredients that soften the horny substance (keratin) that holds the top layer of skin cells together (e.g., urea, alpha hydroxy acids such as lactic/citric/glycolic acid, and allantoin). This helps the dead skin cells fall off, helps the skin keep in more water, and leaves the skin feeling smoother and softer.

NDC Code Structure

  • 69968 - Johnson & Johnson Consumer Inc.

NDC 69968-0437-5

Package Description: 141 g in 1 TUBE

NDC 69968-0437-8

Package Description: 226 g in 1 TUBE

NDC Product Information

Aveeno Baby Soothing Relief Moisturizing with NDC 69968-0437 is a a human over the counter drug product labeled by Johnson & Johnson Consumer Inc.. The generic name of Aveeno Baby Soothing Relief Moisturizing is dimethicone. The product's dosage form is cream and is administered via topical form.

Labeler Name: Johnson & Johnson Consumer Inc.

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Aveeno Baby Soothing Relief Moisturizing Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • DIMETHICONE 12 mg/g

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Johnson & Johnson Consumer Inc.
Labeler Code: 69968
FDA Application Number: part347 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 10-22-2015 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Aveeno Baby Soothing Relief Moisturizing Product Label Images

Aveeno Baby Soothing Relief Moisturizing Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Aveeno Baby® Soothing Relief Moisturizing CreamDrug Facts

Aveeno Baby® Daily Moisture LotionDrug Facts

Aveeno® daily moisturizing lotionDrug Facts

Aveeno® POSITIVELY RADIANT® daily moisturizer sunscreen BROAD SPECTRUM SPF 15Drug Facts

Distributed by:JOHNSON & JOHNSON CONSUMER INC.Skillman, NJ 08558

Active Ingredient

Dimethicone (1.2%)

Dimethicone 1.2%

Dimethicone (1.2%)

Purpose

Skin Protectant

Skin Protectant

Skin protectant

Uses

  • Helps prevent and temporarily protects chafed, chapped or cracked skin

  • Helps prevent and temporarily protects chafed, chapped or cracked skin

  • Helps prevent and temporarily protects chafed, chapped or cracked skinHelps prevent and protect from the drying effects of wind and cold weather

Warnings

For external use only

For external use only

For external use only.

  • For external use only

When Using This Product

  • Do not get into eyes

  • Do not get into eyes

  • Do not get into eyes.

Stop Use And Ask A Doctor If

  • Condition worsensSymptoms last more than 7 days or clear up and occur again within a few days

  • Condition worsensSymptoms last more than 7 days or clear up and occur again within a few days

  • Condition worsensSymptoms last more than 7 days or clear up and occur again within a few days.

Do Not Use On

  • Deep or puncture woundsAnimal bitesSerious burns

  • Deep or puncture woundsAnimal bitesSerious burns

  • Deep or puncture woundsAnimal bitesSerious burns.

Otc - Keep Out Of Reach Of Children

SAFETY TIP: Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Directions

  • Twist off cap, remove quality seal. Apply liberally or as needed. Do not use if quality seal is broken

  • Apply as needed.

Apply as needed.

  • For sunscreen use:apply generously and evenly 15 minutes before sun exposurereapply at least every 2 hoursuse a water resistant sunscreen if swimming or sweatingSun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging . To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:limit time in the sun, especially from 10 a.m. - 2 p.m.wear long-sleeved shirts, pants, hats, and sunglasseschildren under 6 months of age: Ask a doctor

Other Information

Remove quality seal. Do not use if quality seal is broken. Store at room temperature.

  • To open, twist off cap and remove quality seal. Do not use if quality seal is broken.Store at room temperature.

Store at Room Temperature

  • Protect this product from excessive heat and direct sunmay stain some fabrics

Inactive Ingredients

Water, Glycerin, Distearyldimonium Chloride, Petrolatum, Isopropyl Palmitate, Cetyl Alcohol, Avena Sativa (Oat) Kernel Flour, Avena Sativa (Oat) Kernel Extract, Avena Sativa (Oat) Kernel Oil, Butyrospermum Parkii (Shea) Butter, Steareth-20, Sodium Chloride, Benzyl Alcohol

Water, Glycerin, Distearyldimonium Chloride, Petrolatum, Isopropyl Palmitate, Cetyl Alcohol, Avena Sativa (Oat) Kernel Flour, Benzyl Alcohol, Sodium Chloride, Allantoin, Citric Acid

Water, Glycerin, Distearyldimonium Chloride, Petrolatum, Isopropyl Palmitate, Cetyl Alcohol, Avena Sativa (Oat) Kernel Flour, Benzyl Alcohol, Sodium Chloride

Water, C12-15 Alkyl Benzoate, Cetearyl Alcohol, Dimethicone, Glycine Soja (Soyabean) Seed Extract, Phenyl Trimethicone, Glycerin, Arachidyl Alcohol, Cetearyl Glycoside, Phenoxyethanol, Benzyl Alcohol, Panthenol, Ethylene/Acrylic Acid Copolymer, Behenyl Alcohol, Steareth-2, Fragrance, Steareth-21, Polymethyl Methacrylate, Polyacrylamide, Arachidyl Glucoside, Disodium EDTA, C13-14 Isoparaffin, Laureth-7, Silica, Benzalkonium Chloride, Iodopropynyl Butylcarbamate, BHT, Sodium Hydroxide, Citric Acid, Titanium Dioxide, Mica

Questions?

866-428-3366; Outside US, dial collect 215-273-8755 www.aveeno.com

Call toll-free 866-4 AVEENO or 215-273-8755 (collect) www.aveeno.com

866-428-3366; outside US, dial collect 215-273-8755 www.aveeno.com

866-428-3366; Outside US, dial collect 215-273-8755 www.aveeno.com

Otc - Purpose

Active ingredientPurposeAvobenzone 3%SunscreenOctinoxate 7.5%SunscreenOctisalate 2 %Sunscreen

Use

  • Helps prevent sunburnif used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer an early skin aging caused by the sun

Otc - Do Not Use

  • Do not use on damaged or broken skin

Otc - When Using

  • When using this product keep out of eyes. Rinse with water to remove

Otc - Stop Use

  • Stop use and ask a doctor if rash occurs

* Please review the disclaimer below.