SPL v6
SPL
SPL Set ID 4de96ed4-7506-4acd-8e8d-ea74bfd18e4a
Route
TOPICAL
Published
Effective Date 2014-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (2 g)
Inactive Ingredients
Fd&c Blue No. 1 Paraffin Petrolatum Aluminum Starch Octenylsuccinate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 1994-07-31

Description

DRUG FACTS

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

DRUG FACTS

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

Section 42229-5

DRUG FACTS

Section 50570-1

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

For external use only

Purpose:

Antifungal

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 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 a serious adverse event or for product information contact (404) 521-0857.

Other Ingredients

FD&C blue #1, fragrance, paraffin wax, petrolatum, and starch

Active Ingredient:

Miconazole Nitrate 2%

Principal Display Panel

NDC 12258-241-01

Tetterine®

Ointment

Antifungal

Cures: Athlete's Foot,

Jock Itch and Ringworm

Net wt. 1oz. (28.4g.)

Other Packaging Content

Manufactured by S.S.S. Company Atlanta, GA 1-800-237-3843

www.ssspharmaceuticals.com

Rev. B

RETAIN THIS CARTON FOR FUTURE REFERENCE!

When Using This Product
  • Avoid contact with the eyes
Keep Out of Reach of Children

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

Stop Using 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 or if there is no improvement with-in 2 weeks

Structured Label Content

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

Section 42229-5 (42229-5)

DRUG FACTS

Section 50570-1 (50570-1)

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

For external use only

Purpose:

Antifungal

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 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 a serious adverse event or for product information contact (404) 521-0857.

Other Ingredients

FD&C blue #1, fragrance, paraffin wax, petrolatum, and starch

Active Ingredient:

Miconazole Nitrate 2%

Principal Display Panel

NDC 12258-241-01

Tetterine®

Ointment

Antifungal

Cures: Athlete's Foot,

Jock Itch and Ringworm

Net wt. 1oz. (28.4g.)

Other Packaging Content

Manufactured by S.S.S. Company Atlanta, GA 1-800-237-3843

www.ssspharmaceuticals.com

Rev. B

RETAIN THIS CARTON FOR FUTURE REFERENCE!

When Using This Product (When using this product)
  • Avoid contact with the eyes
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.

Stop Using and Ask A Doctor If (Stop using 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 or if there is no improvement with-in 2 weeks

Advanced Ingredient Data


Raw Label Data

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