NDC 65753-200 Coretex Antibacterial Hand Sanitizer

Sd Alcohol

NDC Product Code 65753-200

NDC 65753-200-01

Package Description: 30 mL in 1 BOTTLE

NDC 65753-200-02

Package Description: 59 mL in 1 BOTTLE

NDC 65753-200-03

Package Description: 118 mL in 1 BOTTLE

NDC 65753-200-05

Package Description: 236 mL in 1 BOTTLE

NDC 65753-200-06

Package Description: 354 mL in 1 BOTTLE

NDC 65753-200-07

Package Description: 354 mL in 1 BOTTLE, PUMP

NDC 65753-200-08

Package Description: 500 mL in 1 BOTTLE

NDC 65753-200-10

Package Description: 3785 mL in 1 BOTTLE

NDC 65753-200-20

Package Description: 25 POUCH in 1 CONTAINER > 3.5 mL in 1 POUCH

NDC 65753-200-21

Package Description: 300 POUCH in 1 CONTAINER > 3.5 mL in 1 POUCH

NDC 65753-200-28

Package Description: 118 mL in 1 BOTTLE, PUMP

NDC 65753-200-29

Package Description: 236 mL in 1 BOTTLE, PUMP

NDC 65753-200-30

Package Description: 473 mL in 1 BOTTLE, PUMP

NDC 65753-200-32

Package Description: 44 mL in 1 BOTTLE

NDC Product Information

Coretex Antibacterial Hand Sanitizer with NDC 65753-200 is a a human over the counter drug product labeled by Coretex Products. The generic name of Coretex Antibacterial Hand Sanitizer is sd alcohol. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Coretex Products

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Coretex Antibacterial Hand Sanitizer 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.

  • ALCOHOL 62.5 mL/100mL

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.

  • CANNABIS SATIVA SEED (UNII: QE567Z26NG)
  • FRAGARIA VESCA FRUIT (UNII: CG6IX3GCMU)
  • PUNICA GRANATUM WHOLE (UNII: O2ZTS50U5E)
  • VITIS VINIFERA SEED (UNII: C34U15ICXA)
  • CITRULLUS COLOCYNTHIS FRUIT (UNII: 0E49E3V9U6)
  • EUTERPE OLERACEA WHOLE (UNII: Y57H6218HP)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • HELIANTHUS ANNUUS SEEDCAKE (UNII: 482WYF7XLC)
  • HIPPOPHAE RHAMNOIDES FRUIT JUICE (UNII: UC3P08EB3Y)
  • LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)
  • MYRCIARIA DUBIA FRUIT (UNII: YSW4EM1EKP)
  • PROPYLENE GLYCOL 1-BUTYRATE (UNII: PUV901J64H)
  • RUBUS IDAEUS SEED (UNII: M3CL7US2ZG)
  • VACCINIUM ANGUSTIFOLIUM WHOLE (UNII: R3538BZ1BW)
  • VACCINIUM MACROCARPON WHOLE (UNII: D11KO7O2DX)
  • WATER (UNII: 059QF0KO0R)
  • ACTINIDIA CHINENSIS WHOLE (UNII: 8HTD3WU8LH)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)
  • BRASSICA OLERACEA VAR. ITALICA WHOLE (UNII: DW4954EP53)
  • ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • 1,3-PROPANEDIOL BIS(4-AMINOBENZOATE) (UNII: 8860R9ORQR)

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: Coretex Products
Labeler Code: 65753
FDA Application Number: part333E 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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 11-25-2019 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.

Coretex Antibacterial Hand Sanitizer Product Label Images

Coretex Antibacterial Hand Sanitizer 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 Ingredients

SD Alcohol 40-B 62.5%

Purpose

Antimicrobial

Uses

Hand Sanitizer to help reduce bacteria on the skin.

Warnings

Flammable. Keep away from heat or flame.For external use only.

When Using This Product

Do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop Use And Ask A Doctor

If irritation or rash appears and lasts.

Otc - Keep Out Of Reach Of Children

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

Directions

Put enough product in your palm to cover hands and rub hands together briskly until dry.

Inactive Ingredients

Actinidia chinesis (kiwi) extract, aloe barbadenis leaf juice, aminomethyl propanol, brassica oleracea italica (broccoli) extract, cannabis sativa (hemp) seed extract, carbomer citrullus vulgaris (watermelon) fruit extract, euterpe oleracea fruit extract, fragaria vesca (strawberry) fruit extract, glycerin, helianthus annus (sunfloer) seed oil, hippophae rhamnoides (sea buckthorn) fruit extract, lycium barbarum (goji) extract, myrciaria dubia (camu camu) fruit extract, propanediol, propylene glycol, punica granatum extract, rubus idaeus seed extract, tocopherol acetate (vitamin E acetate), vaccinium angustifolium (blueberry) extract, vaccinium macrocarpon (cranberry) fruit extract, vitis vinifera (grape) seed extra, water

Other Information

Store below 110
oF (43
o), Read the Safety Data Sheet for this Product. You may obtain an SDS from our website: www.coretexproducts.com or Call: 1-877-684-5774

* Please review the disclaimer below.