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NDC 12258-0242-01 White Tetterine 2 g/100g Details

White Tetterine 2 g/100g

White Tetterine is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by S.S.S. Company. The primary component is MICONAZOLE NITRATE.

MedlinePlus Drug Summary

Topical miconazole is used to treat tinea corporis(ringworm; fungal skin infection that causes a red scaly rash on different parts of the body), tinea cruris (jock itch; fungal infection of the skin in the groin or buttocks), and tinea pedis (athlete's foot; fungal infection of the skin on the feet and between the toes). Miconazole is in a class of antifungal medications called imidazoles. It works by stopping the growth of fungi that cause infection. Not all products should be used to treat all of these conditions. Please read the label for each product to select the one to treat your condition.

Related Packages: 12258-0242-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Miconazole Topical

Product Information

NDC	12258-0242
Product ID	12258-242_b3491b38-4148-8d77-e053-2a95a90a4d5b
Associated GPIs	90154050104210
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	White Tetterine
Proprietary Name Suffix	n/a
Non-Proprietary Name	Miconazole Nitrate
Product Type	HUMAN OTC DRUG
Dosage Form	OINTMENT
Route	TOPICAL
Active Ingredient Strength	2
Active Ingredient Units	g/100g
Substance Name	MICONAZOLE NITRATE
Labeler Name	S.S.S. Company
Pharmaceutical Class	Azole Antifungal [EPC], Azoles [CS]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part333C
Listing Certified Through	2024-12-31

Package

Package Images

NDC 12258-0242-01 (12258024201)

Pricing Information	N/A
NDC Package Code	12258-242-01
Billing NDC	12258024201
Package	1 TUBE in 1 CARTON (12258-242-01) / 28.4 g in 1 TUBE
Marketing Start Date	1995-02-28
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 861895df-c989-4afd-bb31-c87c644139ef Details

SPL UNCLASSIFIED SECTION

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.)

INGREDIENTS AND APPEARANCE

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)

Revised: 11/2020

Document Id: b3491b38-4148-8d77-e053-2a95a90a4d5b

Set id: 861895df-c989-4afd-bb31-c87c644139ef

Version: 4

Effective Time: 20201104