NDC 68784-301 Clotrimazole

Clotrimazole

NDC Product Code 68784-301

NDC 68784-301-10

Package Description: 1 BOTTLE in 1 BOX > 10 mL in 1 BOTTLE (68784-301-01)

NDC Product Information

Clotrimazole with NDC 68784-301 is a a human over the counter drug product labeled by Acino Products Limited Liability Company. The generic name of Clotrimazole is clotrimazole. The product's dosage form is solution and is administered via topical form.

Labeler Name: Acino Products Limited Liability Company

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

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.

Clotrimazole 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.

  • CLOTRIMAZOLE 1 g/100mL

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.

  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)

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: Acino Products Limited Liability Company
Labeler Code: 68784
FDA Application Number: part333C 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: 07-29-2019 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.

Clotrimazole 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

CLOTRIMAZOLE USP, 1%

Purpose

ANTIFUNGAL

Uses

Cures most• Athlete's foot (tinea pedis)• Jock Itch (tinea cruris)• Ringworm (tinea corporis)Effectively relieves• Itching• Cracking• Burning• Discomfort which can accompany these conditions• This product is not effective on the scalp or nails. For best results, follow directions and continue treatment for length of time indicated. For athlete's foot and ringworm: use daily for 4 weeks. For jock itch: use daily for 2 weeks.• clean the affected area and dry thoroughly• apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor• supervise children in the use of this product.For athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes; change shoes and socks at least once daily.

Warnings

• For external use onlyAsk a doctor before use on children under 2 years of ageWhen using this product avoid contact with eyesStop use and ask a doctor if• irritation occurs• there is no improvement within 4 weeks (for athlete's foot and ringworm) or 2 weeks (for jock itch)

Otc - Keep Out Of Reach Of Children

Keep out of reach of childrenIf swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • This product is not effective on the scalp or nails. For best results, follow directions and continue treatment for length of time indicated. For athlete's foot and ringworm: use daily for 4 weeks. For jock itch: use daily for 2 weeks.clean the affected area and dry thoroughlyapply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctorsupervise children in the use of this product.For athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes; change shoes and socks at least once daily.

Other Information

Store at 15° to 30°C (59° to 86°F)

Inactive Ingredient

Polyethylene glycol 400

Questions

Call 1-877-227-2594

* Please review the disclaimer below.