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Family care antifungal - Medication Information

Product NDC Code 65923-052
Drug Name

Family care antifungal

Type Brand
Pharm Class Azole Antifungal [EPC],
Azoles [CS]
Active Ingredients
Clotrimazole 10 mg/g
Route TOPICAL
Dosage Form CREAM
RxCUI drug identifier 309367
Application Number part333C
Labeler Name United Exchange Corp.
Packages
Package NDC Code Description
65923-052-28 1 tube in 1 carton (65923-052-28) / 28 g in 1 tube
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Purpose Clotrimazole 1%.............................................................................Antifungal

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Distributed by: United Exchange Corp. 5836 Corporate Ave. Cypress, CA 90630 USA Made in China

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients cetostearly alcohol, ethylparaben, glycerin, light mineral oil, propylene glycol, purified water, sodium sulfite, steareth-20, stearic acid

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Directions wash affected area and dry thoroughly apply a thin layer over affected area twice daily (morning and night) 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 and change shoes and socks at least once daily for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks if condition persists longer, ask a doctor this product is not effective on the scalp or nails

Purpose

Information about the drug product’s indications for use.
Uses cures most athlete's foot, jock itch, and ringworm relieves itching, burning, cracking, scaling and discomfort which accompany these conditions

Spl product data elements

Usually a list of ingredients in a drug product.
Family Care Antifungal Clotrimazole SODIUM SULFITE SULFITE ION STEARETH-20 STEARIC ACID WATER PROPYLENE GLYCOL CLOTRIMAZOLE CLOTRIMAZOLE CETOSTEARYL ALCOHOL ETHYLPARABEN GLYCERIN LIGHT MINERAL OIL

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
505.1

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
Do not use on children under 2 years of age unless directed by a doctor

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop 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)

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
When using this product avoid contact with the eyes

Storage and handling

Information about safe storage and handling of the drug product.
Other information store between 20° to 25°C (68° to 77°F) Lot No. & Exp. Date: see box or see crimp of tube

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings For external use only

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API