84010-064 Completed

84010-064 Completed
SPL v2
SPL
SPL Set ID 2b047ae2-ba82-9947-e063-6394a90a88ca
Route
CUTANEOUS
Published
Effective Date 2025-01-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (1 g)
Inactive Ingredients
Starch, Corn Jojoba Oil Sodium Cocoyl Isethionate Glycerin Shea Butter Eucalyptus Oil Lavender Oil Tea Tree Oil Prunus Amygdalus Dulcis (sweet Almond) Oil Peppermint Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-06 Until 2025-01-14

Description

Miconazole nitrate 1%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Miconazole nitrate 1%

Use

This product helps to treat common fungal infections,including ringworm (tinea corporis), jock itch (tinea cruris),and athlete's foot (tinea pedis). Provides relief from itching,burning, and cracked skin.

Stop Use

Stop use and ask a doctor if condition worsens or does not improve after regular use as directed.

Warnings

For external use only.

Questions

Please contact us at [email protected]

Ask Doctor

Stop use and ask a doctor if condition worsens or does not improve after regular use as directed.

Directions

·Lather: Wet skin and soap bar. Rub soap to create lather.

·Apply: Massage lather onto body and feet, focusing on odor-prone or irritated areas.

·Rinse: Wash off soap with warm

water, ensuring al lather is removed.

·Dry: Pat skin and feet dry thoroughly with a towel.

Do Not Use

Do not use if you are allergic to any of the ingredients.

When Using

When using this product avoid contact with eyes.If contact occurs, rinse the eyes thoroughly with water.

Active Ingredient

Miconazole nitrate 1%

Inactive Ingredients

SODIUM COCOYL ISETHIONATE,STARCH FROM CORN, GLYCERIN,JOJOBA OIL, SHEA BUTTER,SWEET ALMOND OIL, TEA TREE OIL, EUCALYPTUS OIL,PEPPERMINT OIL, LAVENDER ESSENTIAL OIL

Principal Display Panel

Keep Oot of Reach of Children

If swallowed, get medical help or contact a poison control center (1-800-222-1222)right away.


Structured Label Content

Use

This product helps to treat common fungal infections,including ringworm (tinea corporis), jock itch (tinea cruris),and athlete's foot (tinea pedis). Provides relief from itching,burning, and cracked skin.

Purpose

Antifungal

Stop Use

Stop use and ask a doctor if condition worsens or does not improve after regular use as directed.

Warnings

For external use only.

Questions

Please contact us at [email protected]

Ask Doctor

Stop use and ask a doctor if condition worsens or does not improve after regular use as directed.

Directions

·Lather: Wet skin and soap bar. Rub soap to create lather.

·Apply: Massage lather onto body and feet, focusing on odor-prone or irritated areas.

·Rinse: Wash off soap with warm

water, ensuring al lather is removed.

·Dry: Pat skin and feet dry thoroughly with a towel.

Do Not Use (Do not use)

Do not use if you are allergic to any of the ingredients.

When Using

When using this product avoid contact with eyes.If contact occurs, rinse the eyes thoroughly with water.

Active Ingredient

Miconazole nitrate 1%

Inactive Ingredients (Inactive ingredients)

SODIUM COCOYL ISETHIONATE,STARCH FROM CORN, GLYCERIN,JOJOBA OIL, SHEA BUTTER,SWEET ALMOND OIL, TEA TREE OIL, EUCALYPTUS OIL,PEPPERMINT OIL, LAVENDER ESSENTIAL OIL

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

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

If swallowed, get medical help or contact a poison control center (1-800-222-1222)right away.


Advanced Ingredient Data


Raw Label Data

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