NDC 37000-616 Dawn Ultra Antibacterial Hand Apple Blossom Scent

Chloroxylenol

NDC Product Code 37000-616

NDC 37000-616-03

Package Description: 2 BOTTLE, PLASTIC in 1 PACKAGE > 828 mL in 1 BOTTLE, PLASTIC

NDC 37000-616-16

Package Description: 1660 mL in 1 BOTTLE, PLASTIC

NDC 37000-616-20

Package Description: 207 mL in 1 BOTTLE, PLASTIC

NDC 37000-616-22

Package Description: 2210 mL in 1 BOTTLE, PLASTIC

NDC 37000-616-40

Package Description: 1200 mL in 1 BOTTLE, PLASTIC

NDC 37000-616-47

Package Description: 479 mL in 1 BOTTLE, PLASTIC

NDC 37000-616-57

Package Description: 573 mL in 1 BOTTLE, PLASTIC

NDC 37000-616-71

Package Description: 709 mL in 1 BOTTLE, PLASTIC

NDC 37000-616-82

Package Description: 828 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Dawn Ultra Antibacterial Hand Apple Blossom Scent with NDC 37000-616 is a a human over the counter drug product labeled by The Procter & Gamble Manufacturing Company. The generic name of Dawn Ultra Antibacterial Hand Apple Blossom Scent is chloroxylenol. The product's dosage form is soap and is administered via topical form.

Labeler Name: The Procter & Gamble Manufacturing Company

Dosage Form: Soap - Any compound of one or more fatty acids, or their equivalents, with an alkali; soap is detergent and is much employed in liniments, enemas, and in making pills. It is also a mild aperient, antacid and antiseptic.

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.

Dawn Ultra Antibacterial Hand Apple Blossom Scent 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.

  • CHLOROXYLENOL .3 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.

  • C9-11 PARETH-8 (UNII: 80E6PSE1XL)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • ALCOHOL (UNII: 3K9958V90M)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
  • SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • PPG-26 (UNII: V86KZL3H2Z)
  • METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

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: The Procter & Gamble Manufacturing Company
Labeler Code: 37000
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: 07-07-2014 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.

Dawn Ultra Antibacterial Hand Apple Blossom Scent Product Label Images

Dawn Ultra Antibacterial Hand Apple Blossom Scent 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

Other

Drug Facts

Distributed by


PROCTER & GAMBLE,


CINCINNATI, OH 45202

Active Ingredient

Chloroxylenol 0.30%

Purpose

Antibacterial hand soap

Use

  • For handwashing to decrease bacteria on the skin

Warnings

For external use only

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of accidental ingestion, drink a glass of water to dilute. If eye contact occurs, rinse thoroughly with water.

Directions

  • Wet hands and forearms. Apply 5 ml or palmful to hands and forearms. Scrub thoroughly for 30 sec. and rinse.

Inactive Ingredients

Water, sodium lauryl sulfate, lauramine oxide, sodium laureth sulfate, alcohol denat., phenoxyethanol, sodium chloride, C9-11 pareth-8, chloroxylenol, PPG-26, sodium hydroxide, PEI-14 PEG-24/PPG-16 copolymer, fragrance, tetrasodium dicarboxymethyl glutamate, methylisothiazolinone, yellow 5, blue 1.

Questions?

1-800-725-3296

* Please review the disclaimer below.