NDC 49967-744 La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Soothing Therapeutic Multipurpose

Dimethicone

NDC Product Code 49967-744

NDC CODE: 49967-744

Proprietary Name: La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Soothing Therapeutic Multipurpose 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 (including 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 49967-744-01

Package Description: 1 TUBE in 1 CARTON > 40 mL in 1 TUBE

NDC 49967-744-02

Package Description: 1 TUBE in 1 CARTON > 3 mL in 1 TUBE

NDC 49967-744-03

Package Description: 1 mL in 1 PACKET

NDC Product Information

La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Soothing Therapeutic Multipurpose with NDC 49967-744 is a a human over the counter drug product labeled by L'oreal Usa Products Inc. The generic name of La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Soothing Therapeutic Multipurpose is dimethicone. The product's dosage form is cream and is administered via topical form.

Labeler Name: L'oreal Usa Products 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.

La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Soothing Therapeutic Multipurpose 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 10 mg/mL

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.

  • WATER (UNII: 059QF0KO0R)
  • HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
  • TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
  • ZINC GLUCONATE (UNII: U6WSN5SQ1Z)
  • MADECASSOSIDE (UNII: CQ2F5O6YIY)
  • MANGANESE GLUCONATE (UNII: 9YY2F980SV)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
  • MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • COPPER GLUCONATE (UNII: RV823G6G67)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • ACETYLATED GLYCOL STEARATE (UNII: K71M6R9N7E)
  • POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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.

Product Labeler Information

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

Labeler Name: L'oreal Usa Products Inc
Labeler Code: 49967
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: 03-15-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Soothing Therapeutic Multipurpose Product Label Images

La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Soothing Therapeutic Multipurpose 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

Dimethicone 1%

Purpose

Skin protectant

Uses

  • Temporarily protects and helps relieve chafed, chapped or cracked skinhelps protect from the drying effects of wind and cold weatherhelps treat and prevent diaper rashprotects chafed skin due to diaper rash and helps seal out wetness

Warnings

For external use only

Do Not Use

  • On deep or puncture woundsanimal bitesserious burns

When Using This Product

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

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Apply as neededFor diaper rash:change wet and soiled diapers promptly, cleanse the diaper area, and allow to dryapply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

Other Information

● store at room temperature

Inactive Ingredients

Water, hydrogenated polyisobutene, glycerin, butyrospermum parkii (shea) butter, panthenol, aluminum starch octenylsuccinate, butylene glycol, propanediol, cetyl PEG/PPG-10/1 dimethicone, trihydroxystearin, zinc gluconate, madecassoside, manganese gluconate, silica, aluminum hydroxide, magnesium sulfate, disodium EDTA, copper gluconate, citric acid, acetylated glycol stearate, polyglyceryl-4 isostearate, tocopherol, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, sodium benzoate, phenoxyethanol, chlorhexidine digluconate, titanium dioxide

* Please review the disclaimer below.