NDC 11523-0012 Lotrimin Daily Sweat And Odor Control

Topical Starch

NDC Product Code 11523-0012

NDC 11523-0012-1

Package Description: 177 g in 1 BOTTLE

NDC Product Information

Lotrimin Daily Sweat And Odor Control with NDC 11523-0012 is a a human over the counter drug product labeled by Bayer Healthcare Llc.. The generic name of Lotrimin Daily Sweat And Odor Control is topical starch. The product's dosage form is powder and is administered via topical form.

Labeler Name: Bayer Healthcare Llc.

Dosage Form: Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.

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.

Lotrimin Daily Sweat And Odor Control 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.

  • STARCH, CORN 837 mg/g

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.

  • ZINC OXIDE (UNII: SOI2LOH54Z)
  • LEMON OIL (UNII: I9GRO824LL)
  • CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
  • KAOLIN (UNII: 24H4NWX5CO)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • BENZETHONIUM CHLORIDE (UNII: PH41D05744)

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: Bayer Healthcare Llc.
Labeler Code: 11523
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: 02-17-2020 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.

Lotrimin Daily Sweat And Odor Control Product Label Images

Lotrimin Daily Sweat And Odor Control 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

Otc - Active Ingredient

Active ingredientTopical starch 83.7%

Otc - Purpose

PurposeSkin Protectant

Use

Usetemporarily protects and helps relieve minor skin irritation

Warnings

WarningsFor external use only

Otc - Do Not Use

Do not use on broken skin.

Otc - When Using

When using this product• Do not get into eyes• Keep away from face and mouth to avoid breathing it

Otc - Stop Use

  • Stop use and ask a doctor ifCondition worsensSymptoms last more than 7 days or clear up and occur again within a few days

Otc - Keep Out Of Reach Of Children

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

Directions

DirectionsApply as needed

Inactive Ingredient

Inactive ingredientsbenzethonium chloride;camphor (synthetic);eucalyptus oil;kaolin;lemon oil;zinc oxide

Questions

Questions? 1-866-360-3266

Package Display

  • LOTRIMINTOPICAL STARCH SKIN PROTECTANTmedicated foot powderDAILY SWEAT& ODOR CONTROL6 odor-fightingingredients to control odorsuper sweat absorbent powderrelieves irritationtalc-freeNET WT 177 G (6.25 OZ)

* Please review the disclaimer below.