SPL v1
SPL
SPL Set ID 3d0a1e39-82e4-9337-e063-6294a90aa9a3
Route
TOPICAL
Published
Effective Date 2025-08-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (2 g)
Inactive Ingredients
Rhinacanthus Nasutus Whole Viola Patrinii Propylene Glycol Water Gentianella Amarella Root Murraya Paniculata Leafy Twig Trolamine Dimethicone Sophora Flavescens Root Stemona Tuberosa Whole Glycerin Camphor (synthetic) Euphorbia Hirta Peppermint Methylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-23

Description

Miconazole Nitrate 2%.Anti-fungal


Medication Information

Warnings and Precautions

FOR EXTERNAL USE ONLY.

DO NOT USE it on children under 2 yearsof age unless directed by a doctor.WHEN USING THIS PRODUCT,avoidcontact with the eyes, lf contact occurs,rinse the eyes very thoroughly with water.KEEP OUT OF THE REACH OF YOUING CHILDRENSTOP USING AND ASK A PHYSICIANif irritation occurs or there is noirmmprovement within 4 weeks,STOP USE AND ASK A DOCTORif discomfort persists.

Indications and Usage

Treats most folliculitis,tinea capitis, Lichen,.and Psoriasis.Relieves the itching,irritation,redness,scaling,and discomfort accompanyingthese conditions.

Dosage and Administration

Wash the affectedarea and dry thorough-ly.Apply a thin layer over the affected areatwice daily ( morning and night ), or asdirected by a doctor,Supervise children inthe use of the product.lf the conditionpersists longer, consult a doctor.

Description

Miconazole Nitrate 2%.Anti-fungal

Section 50565-1

KEEP OUT OF THE REACH OF YOUING CHILDREN

Section 50566-9

STOP USING AND ASK A PHYSICIANif irritation oocurs or there is no improwement within 4 weeks

Section 51727-6

Water

Camphor(SYNTHETIC)‌

Gentiana‌

Sophora Flavescens

Rhinacanthus Nasutus‌ ‌

Stemona Tuberosa Lour‌ ‌

Herba Violae‌ ‌

Euphorbia Hirta‌ ‌

Murraya Exotica‌ ‌

Peppermint‌ ‌

Glycerin‌

Methylparaben‌

Propylene Glycol‌

Silicone Oil‌

Triethanolamine‌

Section 51945-4

Section 55105-1

FOLLICULITISTINEA CAPITISLICHENPSORIASIS

Section 55106-9

Miconazole Nitrate 2%.Anti-fungal

Section 60561-8

OTHER INFORMATION

Store at 59-86F(15-30°C)Close the cap tightly after use.


Structured Label Content

Indications and Usage (34067-9)

Treats most folliculitis,tinea capitis, Lichen,.and Psoriasis.Relieves the itching,irritation,redness,scaling,and discomfort accompanyingthese conditions.

Dosage and Administration (34068-7)

Wash the affectedarea and dry thorough-ly.Apply a thin layer over the affected areatwice daily ( morning and night ), or asdirected by a doctor,Supervise children inthe use of the product.lf the conditionpersists longer, consult a doctor.

Warnings and Precautions (34071-1)

FOR EXTERNAL USE ONLY.

DO NOT USE it on children under 2 yearsof age unless directed by a doctor.WHEN USING THIS PRODUCT,avoidcontact with the eyes, lf contact occurs,rinse the eyes very thoroughly with water.KEEP OUT OF THE REACH OF YOUING CHILDRENSTOP USING AND ASK A PHYSICIANif irritation occurs or there is noirmmprovement within 4 weeks,STOP USE AND ASK A DOCTORif discomfort persists.

Section 50565-1 (50565-1)

KEEP OUT OF THE REACH OF YOUING CHILDREN

Section 50566-9 (50566-9)

STOP USING AND ASK A PHYSICIANif irritation oocurs or there is no improwement within 4 weeks

Section 51727-6 (51727-6)

Water

Camphor(SYNTHETIC)‌

Gentiana‌

Sophora Flavescens

Rhinacanthus Nasutus‌ ‌

Stemona Tuberosa Lour‌ ‌

Herba Violae‌ ‌

Euphorbia Hirta‌ ‌

Murraya Exotica‌ ‌

Peppermint‌ ‌

Glycerin‌

Methylparaben‌

Propylene Glycol‌

Silicone Oil‌

Triethanolamine‌

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

FOLLICULITISTINEA CAPITISLICHENPSORIASIS

Section 55106-9 (55106-9)

Miconazole Nitrate 2%.Anti-fungal

Section 60561-8 (60561-8)

OTHER INFORMATION

Store at 59-86F(15-30°C)Close the cap tightly after use.


Advanced Ingredient Data


Raw Label Data

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