NDC 51346-310 Super Aqua Max Moisture Watery

Dimethicone

NDC Product Code 51346-310

NDC CODE: 51346-310

Proprietary Name: Super Aqua Max Moisture Watery 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

  • 51346 - Nature Republic Co., Ltd.

NDC 51346-310-01

Package Description: 80 mL in 1 CARTON

NDC Product Information

Super Aqua Max Moisture Watery with NDC 51346-310 is a a human over the counter drug product labeled by Nature Republic Co., Ltd.. The generic name of Super Aqua Max Moisture Watery is dimethicone. The product's dosage form is cream and is administered via topical form.

Labeler Name: Nature Republic Co., Ltd.

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.

Super Aqua Max Moisture Watery 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 6.8 mg/80mL

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)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)

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: Nature Republic Co., Ltd.
Labeler Code: 51346
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: 06-01-2015 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: 12-31-2021 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.

Super Aqua Max Moisture Watery Product Label Images

Super Aqua Max Moisture Watery 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: DIMETHICONE (8.50%)

Inactive Ingredient

INACTIVE INGREDIENTS: SEA WATER,BUTYLENE GLYCOL,CYCLOPENTASILOXANE,HYDROGENATED POLYISOBUTENE,BETAINE,DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER,PEG/PPG-18/18 DIMETHICONE,POLYSORBATE 20,AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER,TRIDECETH-6,GLYCOSYL TREHALOSE,WATER,PHENOXYETHANOL,HYDROGENATED STARCH HYDROLYSATE,AMARANTHUS CAUDATUS SEED EXTRACT,ULMUS DAVIDIANA ROOT EXTRACT,SODIUM POLYACRYLATE,PIPER METHYSTICUM LEAF/ROOT/STEM EXTRACT,FRAGRANCE,PORTULACA OLERACEA EXTRACT,PUERARIA THUNBERGIANA ROOT EXTRACT,CNIDIUM OFFICINALE ROOT EXTRACT,GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT,PAEONIA LACTIFLORA ROOT EXTRACT,SARGASSUM MUTICUM EXTRACT,AGARUM CRIBOSUM EXTRACT,CHLORELLA MINUTISSIMA EXTRACT,CODIUM FRAGILE EXTRACT,CODIUM TOMENTOSUM EXTRACT,DUNALIELLA SALINA EXTRACT,ECKLONIA CAVA EXTRACT,ENTEROMORPHA COMPRESSA EXTRACT,FUCUS VESICULOSUS EXTRACT,GELIDIUM CARTILAGINEUM EXTRACT,HAEMATOCOCCUS PLUVIALIS EXTRACT,HIZIKIA FUSIFORME EXTRACT,HYDROLYZED ALGAE EXTRACT,HYDROLYZED ULVA LACTUCA EXTRACT,HYPNEA MUSCIFORMIS EXTRACT,JANIA RUBENS EXTRACT,LACTOBACILLUS/ALGAE EXTRACT FERMENT,LAMINARIA CLOUSTONI EXTRACT,LAMINARIA DIGITATA EXTRACT,LAMINARIA JAPONICA EXTRACT,LAMINARIA SACCHARINA EXTRACT,MACROCYSTIS PYRIFERA EXTRACT,PIKEA ROBUSTA EXTRACT,PORPHYRA YEZOENSIS EXTRACT,SALICORNIA HERBACEA EXTRACT,SARGASSUM FULVELLUM EXTRACT,SPIRULINA PLATENSIS EXTRACT,ULVA LACTUCA EXTRACT,UNDARIA PINNATIFIDA EXTRACT,XANTHAN GUM,ALGAE EXTRACT,SOLUBLE COLLAGEN,SODIUM HYALURONATE,ALOE BARBADENSIS LEAF JUICE,HYDROGENATED LECITHIN,ALGAE OLIGOSACCHARIDES,CHLORELLA FERMENT,MACROCYSTIS PYRIFERA (KELP) PROTEIN,METHYLISOTHIAZOLINONE,CI 14700,YELLOW 5

Purpose

Purpose: [SKIN MOISTURIZING] The watery cream keeps the skin moisturized by maintaining moisture level for long hours.

Cautions

CAUTIONS: For external use only. Avoid contact with eyes and mouth. Discontinue use if signs of irritation or rashes appear. Keep out of reach of children. Replace the cap after use.

Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN

How To Use

HOW TO USE: At the last step of skin care, apply an appropriate amount to the entire face, and gently pat for absorption.

HOW TO USE: At the last step of skin care, apply an appropriate amount to the entire face, and gently pat for absorption.

* Please review the disclaimer below.