NDC 10967-675 Eight Hour Night

Dimethicone

NDC Product Code 10967-675

NDC CODE: 10967-675

Proprietary Name: Eight Hour Night 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

NDC 10967-675-16

Package Description: 45 g in 1 JAR

NDC Product Information

Eight Hour Night with NDC 10967-675 is a a human over the counter drug product labeled by Revlon. The generic name of Eight Hour Night is dimethicone. The product's dosage form is emulsion and is administered via topical form.

Labeler Name: Revlon

Dosage Form: Emulsion - A dosage form consisting of a two-phase system comprised of at least two immiscible liquids1, one of which is dispersed as droplets (internal or dispersed phase) within the other liquid (external or continuous phase), generally stabilized with one or more emulsifying agents. (Note: Emulsion is used as a dosage form term unless a more specific term is applicable, e.g. cream, lotion, ointment.)

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.

Eight Hour Night 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 2 mg/g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • SALICYLIC ACID (UNII: O414PZ4LPZ)
  • .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
  • LIMONENE, (+)- (UNII: GFD7C86Q1W)
  • GLYCERYL BEHENATE/EICOSADIOATE (UNII: 73CJJ317SR)
  • ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
  • SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
  • HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • OLEYL ERUCATE (UNII: 753W099NQ6)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • CORN OIL (UNII: 8470G57WFM)
  • ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
  • MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
  • LANOLIN (UNII: 7EV65EAW6H)
  • DIMETHICONOL (100000 CST) (UNII: OSA9UP217S)
  • GERANIOL (UNII: L837108USY)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • POLYPROPYLENE (30000 MW) (UNII: T71QXI2O62)
  • HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)

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: Revlon
Labeler Code: 10967
FDA Application Number: part352 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: 10-20-2020 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: 12-31-2021 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.

Eight Hour Night Product Label Images

Eight Hour Night 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

Active Ingredient

Active Ingredient Purpose

Dimethicone 2.0%...................................... Skin Protectant

Inactive Ingredients

PETROLATUM, MICROCRYSTALLINE WAX/CERA MICROCRISTALLINA/CIRE MICROCRISTALLINE, LANOLIN, ISONONYL ISONONANOATE, HYDROGENATED POLYISOBUTENE, ISOPROPYL MYRISTATE, ISOPROPYL PALMITATE, BUTYROSPERMUM PARKII (SHEA) BUTTER, POLYBUTENE, TRIISOSTEARIN, OLEYL ERUCATE, POLYPROPYLENE, MINERAL OIL/PARAFFINUM LIQUIDUM/HUILE MINERALE, SYNTHETIC WAX, CYCLOPENTASILOXANE, RICINUS COMMUNIS (CASTOR) SEED OIL, GLYCERYL BEHENATE/EICOSADIOATE, HYDROGENATED LECITHIN, DIMETHICONOL, GLYCERYL CITRATE/LACTATE/LINOLEATE/OLEATE, PARFUM/FRAGRANCE, SALICYLIC ACID, TOCOPHEROL, TOCOPHERYL ACETATE, VEGETABLE OIL/OLUS/HUILE VEGETALE, ALPHA-ISOMETHYL IONONE, BENZYL SALICYLATE, CITRONELLOL, GERANIOL, LIMONENE, LINALOOL, YELLOW 6 LAKE (CI 15985).

Uses And Directions

Uses

- Treats symptoms of chapped or cracked skin.

- Helps prevent and protect from drying effects of wind and cold weather.
Directions- Apply liberally as often as necessary

Warnings

Warnings

For external use only

When using this product

- Avoid contact with eyes
- Do not apply over puncture wounds, infections or lacerationsStop using and ask a doctor if

- Symptoms persist more than 7 days

* Please review the disclaimer below.