NDC 76849-201 Topical Analgesic 0.10 %

Menthol

NDC Product Code 76849-201

NDC 76849-201-11

Package Description: 1 BLISTER PACK in 1 CARTON > 10 VIAL in 1 BLISTER PACK > 1 mL in 1 VIAL

NDC Product Information

Topical Analgesic 0.10 % with NDC 76849-201 is a a human over the counter drug product labeled by Rinati Skin, Llc. The generic name of Topical Analgesic 0.10 % is menthol. The product's dosage form is cream and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 200066.

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Topical Analgesic 0.10 % 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.


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.

  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • OCIMUM TENUIFLORUM WHOLE (UNII: 7OS52KZ33J)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
  • WATER (UNII: 059QF0KO0R)
  • WITHANIA SOMNIFERA ROOT (UNII: V038D626IF)
  • PIPER NIGRUM WHOLE (UNII: 49L10LI8DN)
  • GLUCONOLACTONE (UNII: WQ29KQ9POT)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T)
  • CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT)

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: Rinati Skin, Llc
Labeler Code: 76849
FDA Application Number: part348 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: 08-23-2021 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 - 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.

Topical Analgesic 0.10 % Product Label Images

Topical Analgesic 0.10 % 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 Ingredients

Menthol 0.10%

Purpose

TOPICAL ANALGESIC

Uses

For the temporary relief of pain from minor burns, sunburn, minor cuts, scrapes, and insect bites.

Warnings

For external use only. When using this product ■ Avoid contact with eyes. In case of eye contact, flush eyes with water. ■ If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.

■ Keep Out Of Reach Of Children.

If swallowed, get medical help.

Directions For Use

■ Adults and children 2 years of age or older:


Apply to the desired area and gently rub into the skin, not more than


3 to 4 times daily. ■ Children under the age of 2: Consult a physician.

Inactive Ingredients

Propylene Glycol, Ocimum Tenuiflorum Callus Culture Lysate, Glycerin, Dimethyl Sulfone, Water, Withania Somnifera Root Extract, Piper Nigrum (Pepper) Fruit Extract, Gluconolactone, Sodium Benzoate, Citric Acid, Xanthan Gum, Citrus Aurantium Dulcis (Orange) Oil, Hydroxyethylcellulose.

Other Information

■ Storage Instructions: Store in a cool, dark place (<100°F). Avoid storage directly in sunlight.

* Please review the disclaimer below.