NDC 41190-083 Shoprite

NDC Product Code 41190-083

NDC 41190-083-01

Package Description: 1 TUBE in 1 CARTON > 15 g in 1 TUBE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Shoprite with NDC 41190-083 is a product labeled by Wakefern Food Corporation. The generic name of Shoprite is . The product's dosage form is and is administered via form.

Labeler Name: Wakefern Food Corporation

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.

  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • CETYL PALMITATE (UNII: 5ZA2S6B08X)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Wakefern Food Corporation
Labeler Code: 41190
Start Marketing Date: 07-02-2007 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: 12-31-2019 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: I - INACTIVATED, the listing data was inactivated by the FDA. 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".

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Information for Patients

Terbinafine

Terbinafine is pronounced as (ter' bin a feen)

Why is terbinafine medication prescribed?
Terbinafine granules are used to treat fungal infections of the scalp. Terbinafine tablets are used to treat fungal infections of the toenails and fingernails. Terbinafi...
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Shoprite 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

Distributed by: Wakefern Food Corp.5000 Riverside DriveKeasbey, NJ 08832

Active Ingredient

Terbinafine hydrochloride 1%

Purpose

Antifungal

Uses

  • Cures most athlete's foot (tinea pedis)cures most jock itch (tinea cruris) and ringworm (tinea corporis)relieves itching, burning, cracking and scaling which accompany these conditions

Warnings

For external use only

Do Not Use

  • On nails or scalpin or near the mouth or the eyesfor vaginal yeast infections

Otc - When Using

When using this product do not get into the eyes. If eye contact occurs, rinse thoroughly with water.

Stop Use And Ask A Doctor If

  • Too much irritation occurs or gets worse.

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 1-800-222-1222.

Directions

  • Adults and children 12 years and olderuse the tip of the cap to break the seal and open the tubewash the affected skin with soap and water and dry completely before applyingfor athlete's foot wear well-fitting, ventilated shoes. Change shoes and socks at least once daily.between the toes only: apply twice a day (morning and night) for 1 week or as directed by a doctor.on the bottom or sides of the foot: apply twice a day (morning and night) for 2 weeks or as directed by a doctor.for jock itch and ringworm: apply once a day (morning or night) for 1 week or as directed by a doctor.wash hands after each usechildren under 12 years: ask a doctor1 weekbetween the toes2 weeks on the bottomor sides of the foot

Other Information

  • Do not use if seal on tube is broken or is not visiblestore at controlled room temperature 20°-25°C (68°-77°F)see carton or tube crimp for lot number and expiration date

Inactive Ingredients

Benzyl alcohol, cetyl alcohol, cetyl palmitate, isopropyl myristate, polysorbate 60, purified water, sodium hydroxide, sorbitan monostearate, stearyl alcohol.

Questions?

Call 1-800-ShopRite

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