NDC 58668-5971 Clarins - Roll-on Deodorant Aluminum Chlorohydrate - Antiperspirant, Long-lasting, Alcohol-free

Aluminum Chlorohydrate

NDC Product Code 58668-5971

NDC CODE: 58668-5971

Proprietary Name: Clarins - Roll-on Deodorant Aluminum Chlorohydrate - Antiperspirant, Long-lasting, Alcohol-free What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Aluminum Chlorohydrate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 58668 - Laboratoires Clarins
    • 58668-5971 - Clarins - Roll-on Deodorant Aluminum Chlorohydrate - Antiperspirant, Long-lasting, Alcohol-free

NDC 58668-5971-1

Package Description: 50 mL in 1 BOTTLE

NDC Product Information

Clarins - Roll-on Deodorant Aluminum Chlorohydrate - Antiperspirant, Long-lasting, Alcohol-free with NDC 58668-5971 is a a human over the counter drug product labeled by Laboratoires Clarins. The generic name of Clarins - Roll-on Deodorant Aluminum Chlorohydrate - Antiperspirant, Long-lasting, Alcohol-free is aluminum chlorohydrate. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Laboratoires Clarins

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.

Clarins - Roll-on Deodorant Aluminum Chlorohydrate - Antiperspirant, Long-lasting, Alcohol-free 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.

  • ALUMINUM CHLOROHYDRATE 140 mg/mL

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.

  • WATER (UNII: 059QF0KO0R)
  • DIPROPYLENE GLYCOL (UNII: E107L85C40)
  • METHYL GLUCETH-20 (UNII: J3QD0LD11P)
  • POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
  • HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • ROSEMARY (UNII: IJ67X351P9)
  • HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)
  • AGATHOSMA BETULINA LEAF (UNII: 369DDH39Z0)

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: Laboratoires Clarins
Labeler Code: 58668
FDA Application Number: part350 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: 02-01-2021 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 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.

Clarins - Roll-on Deodorant Aluminum Chlorohydrate - Antiperspirant, Long-lasting, Alcohol-free Product Label Images

Clarins - Roll-on Deodorant Aluminum Chlorohydrate - Antiperspirant, Long-lasting, Alcohol-free 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

ALUMINUM CHLOROHYDRATE 14%(Anhydrous) w/w

Purpose

Antiperspirant

Uses:

• Reduces underarm perspiration.

Warnings:

For external use only.

Do Not Use

  • On broken skin. Stop use if rash or irritation occurs

Ask A Doctor Before Use

  • If you have kidney disease.

Stop Use And Ask A Doctor

  • If skin irritation or sensitivity develops or increases.

Keep Out Of Reach Of Children.

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

Directions:

• Apply to underarms only.

Inactive Ingredient:

WATER . DIPROPYLENE GLYCOL . METHYL GLUCETH-20 . FRAGRANCE . PEG-40 HYDROGENATED CASTOR OIL . HYDROXYETHYLCELLULOSE . BUTYLENE GLYCOL . POLYSORBATE 20 . GLYCERIN . PHENOXYETHANOL . DISODIUM EDTA . ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT . HAMAMELIS VIRGINIANA (WITCH HAZEL) LEAF EXTRACT . BAROSMA BETULINA LEAF EXTRACT. [C0493C]

Other Information:

• Store at 20-25°C (68-77°F)

* Please review the disclaimer below.