84746-008

84746-008
SPL v1
SPL
SPL Set ID 31c92743-d3e2-a4ca-e063-6294a90aa481
Route
TOPICAL
Published
Effective Date 2025-04-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (2 g)
Inactive Ingredients
Cnidium Monnieri Whole Glycyrrhetinic Acid Rubus Chingii Whole Periploca Sepium Whole Smilax Glabra Whole Pseudolarix Amabilis Whole Stemona Tuberosa Whole Mentha Arvensis Leaf Sophora Flavescens Whole

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-02

Description

Miconazole Nitrate 2%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Miconazole Nitrate 2%

Use

Proven clinically effective in the treatment of most athlete's foot, jock itch and ringworm. For effective relief of itching, scaling, burning and discomfort

Stop Use

Stop use if irritation occurs there is no improvement within 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock itch)

Warnings

For external use only.

Questions

Questions?

[email protected]

Ask Doctor

If condition persists longer, consult a doctor

Directions

-wash the affected area and dry thoroughly

-apply a thin layer of the product over 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

not effective on the scalp or nails

Do Not Use

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

When Using

When using this product avoide contact with eyes

Active Ingredient

Miconazole Nitrate 2%

Other Information

Store at 59-86℉ (15-30℃)

Close the cap tightly after use.

Inactive Ingredients

Smilax Glabra, Sophora Flavescens, Cnidium Monnier(L)Cuss, Fructus Kochiae, Pseudolarixamabillis,Cortex Dictamni,Stemona tuberosalour,Mentha, Glycyrrhetinic Acid.

Principal Display Panel

Keep Oot of Reach of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).


Structured Label Content

Use

Proven clinically effective in the treatment of most athlete's foot, jock itch and ringworm. For effective relief of itching, scaling, burning and discomfort

Purpose

Antifungal

Stop Use

Stop use if irritation occurs there is no improvement within 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock itch)

Warnings

For external use only.

Questions

Questions?

[email protected]

Ask Doctor

If condition persists longer, consult a doctor

Directions

-wash the affected area and dry thoroughly

-apply a thin layer of the product over 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

not effective on the scalp or nails

Do Not Use (Do not use)

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

When Using

When using this product avoide contact with eyes

Active Ingredient

Miconazole Nitrate 2%

Other Information (Other information)

Store at 59-86℉ (15-30℃)

Close the cap tightly after use.

Inactive Ingredients (Inactive ingredients)

Smilax Glabra, Sophora Flavescens, Cnidium Monnier(L)Cuss, Fructus Kochiae, Pseudolarixamabillis,Cortex Dictamni,Stemona tuberosalour,Mentha, Glycyrrhetinic Acid.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Oot of Reach of Children (Keep Oot Of Reach Of Children)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).


Advanced Ingredient Data


Raw Label Data

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