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

Warnings

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.)

Other Packaging Content

S.S.S. Company

Atlanta, GA 30315

MADE IN U.S.A.

Manufactured by S.S.S. Company Atlanta, GA

See our online catalog at www.ssspharmaceuticals.com Rev. B

WHITE TETTERINE
miconazole nitrate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:12258-242
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	2 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
PARAFFIN (UNII: I9O0E3H2ZE)
PETROLATUM (UNII: 4T6H12BN9U)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:12258-242-01	1 in 1 CARTON	02/28/1995
1		28.4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333C	02/28/1995

Labeler - S.S.S. Company (003288321)

Name	Address	ID/FEI	Business Operations
Establishment
S.S.S. Company		003288321	manufacture(12258-242) , pack(12258-242) , label(12258-242)