White Tetterine Ointment
FDA Label NDC 12258-242

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by S.s.s. Company for the product White Tetterine (NDC 12258-242). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient:, purpose:, uses, otc - do not use, stop use and ask a doctor if, when using this product, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Active Ingredient:

→ Purpose:

→ Uses

→ Otc - Do Not Use

→ Stop Use And Ask A Doctor If

→ When Using This Product

→ Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Other Ingredients

→ Principal Display Panel

Other

DRUG FACTS

Active Ingredient:

Miconazole Nitrate 2%

Purpose:

Antifungal

Uses

treats most athlete's foot, jock itch and ringworm. Relieves itching, scaling, cracking, burning, redness, soreness, irritation, discomfort, and chafing associated with jock itch. Relieves itchy, scaly skin between the toes or itching, burning feet associated with athlete's foot

Ask your health professional regarding additional uses

Otc - Do Not Use

Do not use on children under 2 years of age unless directed by a doctor

Do not use on diaper rash

For external use only

Stop Use And Ask A Doctor If

for athlete's foot and ringworm, irritation occurs or if there is no improvement within 4 weeks
for jock itch if irritation occurs of if there is no improvement with-in 2 weeks

When Using This Product

Avoid contact with eyes

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away

Directions

Clean the affected area and dry thoroughly. Apply a thin layer of the product over the 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 the 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 consult a doctor. This product is not effective on the scalp or nails.

Other Information

store at 15°-30°C (59°-86°F).

To report an adverse event or obtain product information, contact (404) 521-0857.

Other Ingredients

Fragrance, paraffin wax, petrolatum, and starch

Principal Display Panel

NDC 12258-242-01

Tetterine® OINTMENT

Antifungal

Cures: Athlete's Foot, Jock Itch and Ringworm

Net wt. 1oz. (28.4 g.)