NDC 51879-802 Tecnu Calagel

Diphenhydramine Hydrochloride

NDC Product Code 51879-802

NDC 51879-802-06

Package Description: 1 BOTTLE in 1 CARTON > 178.9 g in 1 BOTTLE (51879-802-66)

NDC 51879-802-44

Package Description: 144 PACKET in 1 CARTON > 1.86 g in 1 PACKET (51879-802-16)

NDC 51879-802-66

Package Description: 178.9 g in 1 BOTTLE

NDC Product Information

Tecnu Calagel with NDC 51879-802 is a a human over the counter drug product labeled by Tec Laboratories Inc.. The generic name of Tecnu Calagel is diphenhydramine hydrochloride. The product's dosage form is gel and is administered via topical form.

Labeler Name: Tec Laboratories Inc.

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

Tecnu Calagel 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.

  • DIPHENHYDRAMINE HYDROCHLORIDE 20 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.

  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • ZINC ACETATE (UNII: FM5526K07A)
  • HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)
  • WATER (UNII: 059QF0KO0R)
  • MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
  • BENZETHONIUM CHLORIDE (UNII: PH41D05744)
  • BISULFITE ION (UNII: OJ9787WBLU)
  • EDETIC ACID (UNII: 9G34HU7RV0)

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: Tec Laboratories Inc.
Labeler Code: 51879
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: 06-20-2019 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: 12-31-2020 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.

Tecnu Calagel 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

Otc - Active Ingredient

Diphenhydramine HCL 2%

Otc - Purpose

Purpose Topical analgesic / antihistamine

Indications & Usage

For temporary relief of pain and itching associated with:•minor burns •sunburn •minor cuts •scrapes •insect bites•minor skin irritationsrashes due to: •poison oak •poison ivy •poison sumac

Warnings

DO NOT USE:•if allergic to sulfites •on children under 2 years of age unless directed by a doctor•with any other products containing diphenydramine, even one taken by mouth•on deep puncture wounds, animal bites or serious burns unless directed by a doctor•on large areas of the body

Otc - Ask Doctor

•on chicken pox •on measles

Otc - Keep Out Of Reach Of Children

When using this product:•KEEP OUT OF REACH OF CHILDREN•if swallowed, get medical help or contact a poison control center right away•avoid contact with eyes

Otc - Stop Use

Stop use and ask a doctor if: •condition worsens•symptoms persist for more than 7 days or clear up and occur again within a few days

Dosage & Administration

Directions •do not use more often than directed•adults and children 2 years of age and older•cleanse skin with soap and warm water and dry affected area•apply to affected area not more than 3 times daily•may be covered with a sterile bandage, if bandaged, let dry first•children under 2 years of age do not use, consult a doctor

Storage And Handling

Other Information Store at 59 to 86ºF (15 to 30ºC)

Inactive Ingredient

Benzethonium chloride, disodium EDTA, fragrance, hypromellose,menthol, polysorbate 20, purified water, sodium metabisulfite, zinc acetate

Otc - Questions

Questions? Call 1-800-482-4464serious side effects may be reported to this number.

* Please review the disclaimer below.