10967-626 NDC - REVLON MITCHUM CLINICAL STRENGTH SOFT SOLID (ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY LIQUID)

Drug Information

Product NDC: 10967-626

Proprietary Name: Revlon Mitchum Clinical Strength Soft Solid

Non Proprietary Name: Aluminum Zirconium Tetrachlorohydrex Gly liquid

Active Ingredient(s):
  • .2 g/mL ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY


Administration Route(s): TOPICAL

Dosage Form(s): LIQUID

Labeler Information

Labeler Name: Revlon Consumer Products Corp
Product Type: HUMAN OTC DRUG
FDA Application Number: part350
Marketing Category: OTC MONOGRAPH FINAL
Start Marketing Date:1/1/2014

Package Information

No. Package Code Package Description Billing Unit
110967-626-1647 mL in 1 CONTAINER (10967-626-16)
210967-626-2470 mL in 1 CONTAINER (10967-626-24)
310967-626-5014 mL in 1 CONTAINER (10967-626-50)

NDC Record

Field Name Field Value Definition
PRODUCT NDC10967-626The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN OTC DRUGIndicates 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.
PROPRIETARY NAMERevlon Mitchum Clinical Strength Soft SolidThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEAluminum Zirconium Tetrachlorohydrex Gly liquidThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMELIQUIDThe translation of the dosage form Code submitted by the firm.
ROUTE NAMETOPICALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE1/1/2014This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEOTC MONOGRAPH FINALProduct 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.
APPLICATION NUMBERpart350This 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.
LABELER NAMERevlon Consumer Products CorpName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLYThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH.2 
ACTIVE INGRED UNITg/mL 

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This page was last updated on: 11/18/2019