NDC 54340-145 Dial Complete White Tea

Antibacterial Hand Wash White Tea

NDC Product Code 54340-145

NDC 54340-145-01

Package Description: 221 mL in 1 BOTTLE, DISPENSING

NDC Product Information

Dial Complete White Tea with NDC 54340-145 is a a human over the counter drug product labeled by Henkel Corporation. The generic name of Dial Complete White Tea is antibacterial hand wash white tea. The product's dosage form is solution and is administered via topical form.

Labeler Name: Henkel Corporation

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

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.

Dial Complete White Tea 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.

  • BENZALKONIUM CHLORIDE .13 g/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.

  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • EDETATE SODIUM (UNII: MP1J8420LU)
  • WATER (UNII: 059QF0KO0R)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
  • LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
  • CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
  • PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
  • DIMETHYL LAURAMINE (UNII: 6V2OM30I1Z)
  • ZINC SULFATE (UNII: 89DS0H96TB)
  • MYRISTAMIDOPROPYLAMINE OXIDE (UNII: 3HSF539C9T)
  • LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • DIMETHYL MYRISTAMINE (UNII: 5E4O85D8T2)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • ALCOHOL (UNII: 3K9958V90M)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • EDETATE SODIUM (UNII: MP1J8420LU)
  • WATER (UNII: 059QF0KO0R)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
  • CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
  • PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
  • DIMETHYL LAURAMINE (UNII: 6V2OM30I1Z)
  • ZINC SULFATE (UNII: 89DS0H96TB)
  • MYRISTAMIDOPROPYLAMINE OXIDE (UNII: 3HSF539C9T)
  • LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • DIMETHYL MYRISTAMINE (UNII: 5E4O85D8T2)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • ALCOHOL (UNII: 3K9958V90M)
  • FD&C RED NO. 4 FREE ACID (UNII: WJE3T5596E)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
  • EDETATE SODIUM (UNII: MP1J8420LU)
  • WATER (UNII: 059QF0KO0R)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
  • LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
  • PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
  • DIMETHYL LAURAMINE (UNII: 6V2OM30I1Z)
  • ZINC SULFATE (UNII: 89DS0H96TB)
  • MYRISTAMIDOPROPYLAMINE OXIDE (UNII: 3HSF539C9T)
  • LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • DIMETHYL MYRISTAMINE (UNII: 5E4O85D8T2)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • ALCOHOL (UNII: 3K9958V90M)
  • D&C RED NO. 33 (UNII: 9DBA0SBB0L)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
  • EDETATE SODIUM (UNII: MP1J8420LU)
  • WATER (UNII: 059QF0KO0R)
  • D&C RED NO. 33 (UNII: 9DBA0SBB0L)
  • CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
  • PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
  • DIMETHYL LAURAMINE (UNII: 6V2OM30I1Z)
  • ZINC SULFATE (UNII: 89DS0H96TB)
  • MYRISTAMIDOPROPYLAMINE OXIDE (UNII: 3HSF539C9T)
  • LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • DIMETHYL MYRISTAMINE (UNII: 5E4O85D8T2)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • ALCOHOL (UNII: 3K9958V90M)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)

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: Henkel Corporation
Labeler Code: 54340
FDA Application Number: part333A 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: 05-01-2020 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.

Dial Complete White Tea 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

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Uses

For Handwashing to decreases bacteria on the skin.

Warnings

For externernal use only.

When Using This Product

Avoid Contact with eyes. In case of eye contact, flush with water.

Stop Use And Ask Doctor If

Irritation or redness develops

Keep Out Of Reach Of Children.

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

Directions

  • Pump in to hands, wet as needed.Later vigorously for at least 15 seconds.Wash skin, rinse thoroughly and dry.

Inactive Ingredients

GoldAqua (Water, Eau)· Lauramidopropylamine Oxide· Glycerin· Cetrimonium Chloride· Lauramine Oxide· Sodium Chloride·

PEG-120 Methyl Glucose Dioleate · Citric Acid · Sodium Benzoate · Myristamidopropylamlne Oxide · Zinc Sulfate ·

Parfum (Fragrance) • Dimethyl Lauramine • Tetrasodium EDTA ·Alcohol· Dimethyl Myrlstamine · Cl 19140 (Yellow 5) • Cl 14700 (Red 4)
AloeAqua (Water, Eau)• Lauramidopropylamine Oxide· Glycerin· Cetrimonium Chloride· Lauramine Oxide· Sodium Chloride·

PEG-120 Methyl Glucose Dioleate · Citric Acid · Sodium Benzoate · Myristamidopropylamine Oxide · Parfum (Fragrance)

· Zinc Sulfate · Aloe Barbadensis Leaf Juice· Dimethyl Lauramlne · Tetrasodium EDTA ·Alcohol· Dimethyl Myristamine

· Cl 19140 (Yellow 5) · Cl 42090 (Blue 1)
Spring WaterAqua (Water, Eau)· Lauramidopropylamine Oxide· Glycerin· Cetrimonium Chloride· Lauramine Oxide· Sodium Chloride·

PEG-120 Methyl Glucose Dioleate · Citric Acid · Sodium Benzoate · Myristamidopropylamine Oxide · Parfum (Fragrance) •

Zinc Sulfate • Dimethyl Lauramine • Tetrasodium EDTA ·Alcohol· Dimethyl Myristamine · Cl 42090 (Blue 1) · Cl 17200 (Red 33)
White TeaAqua (Water, Eau) · Lauramidopropylamine Oxide · Glycerin · Lauramine Oxide · Cetrimonium Chloride·

Sodium Chloride· PEG-120 Methyl Glucose Dioleate · Citric Acid· Sodium Benzoate · Myristamidopropylam!ne Oxide·

Parfum (Fragrance)· Zinc Sulfate· Dimethyl Lauramine • Tetrasodium EDTA · Alcohol· Camellia Sinensis Leaf Extract·

Dimethyl Myristamine · Cl 42090 (Blue 1) · Cl 17200 (Red 33)

Questions

Call 1-800-258-DIAL(3425)

Www.dialsoap.comhenkel Bean LogoR,TM,c2019 Distributed byHenkel Corporation,Rocky Hill, CT 06067

^Encountered In Household Settings

#Antibacterial Hand Soap

Indications & Usage

For handwasing to decrease bacteria on the skin.

Topical Liquid

Liquid Hand Soap

* Please review the disclaimer below.