Initial Drug Listing - Hermon Folliculitis Cream

Initial Drug Listing - Hermon Folliculitis Cream
SPL v2
SPL
SPL Set ID 3155dd5e-621b-358e-e063-6294a90a90f8
Route
TOPICAL
Published
Effective Date 2025-04-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (1.5 g)
Inactive Ingredients
Viola Philippica Whole Peppermint Cnidium Monnieri Fruit Glyceryl Monostearate Murraya Paniculata Whole Dimethicone Bassia Scoparia Whole Dianthus Superbus Flowering Top Mineral Oil Sophora Flavescens Root Glycerin Stearic Acid Dictamnus Dasycarpus Root Bark Petrolatum Water Rhinacanthus Nasutus Leaf Smilax Glabra Tuber Peg-100 Stearate Euphorbia Hirta Borneol Chlorhexidine Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-20

Description

Miconazole Nitrate 1.5%


Medication Information

Warnings and Precautions

For external use only

Indications and Usage
  • Treats most folliculitis, tinea capitis, lichen, and psoriasis.
  • Relieves the itching, irritation, redness, scaling and discomfort accompanying thee conditions.
Dosage and Administration
  • Wash the affected area and dry thoroughly.
  • Apply a thin layer over the affected area twice daily (morning and night), or as directed by a doctor.
  • Supervise children in the use of the product.
  • If the condition persists longer, consult a doctor.
Description

Miconazole Nitrate 1.5%

Section 50565-1

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

If irritation occurs or there is no improvement within 4 weeks.

Section 50567-7

avoid contact with eyes. If contact occurs, rinse the eyes thoroughly with water.

keep out of the reach of Children.

Section 50570-1

it on children under 2 years of age unless directed by a doctor.

Section 51727-6

Water, Dimethicone, Mineral Oil, Petrolatum, Glycerin, Glyceryl Monostearate, Glyceryl Stearate, PEG-100 Stearate, Stearic Acid, Rhinacanthus nasutus Leaf, Viola philippica Whole, Euphorbia hirta Whole, Murraya paniculata Whole, Mentha haplocalyx Oil, Borneol, Sophora flavescens Root, Cnidium monnieri Fruit, Bassia scoparia Whole, Dictamnus dasycarpus Root Bark, Smilax glabra Tuber, Dianthus superbus Flowering Top, Chlorhexidine Acetate

Section 51945-4

Section 53413-1

contact us at [email protected]

Section 55105-1

Anti-fungal

Section 55106-9

Miconazole Nitrate 1.5%

Section 60561-8
  • Store at 59-85 ºF(15-30 ºC)
  • 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 accompanying thee conditions.
Dosage and Administration (34068-7)
  • Wash the affected area and dry thoroughly.
  • Apply a thin layer over the affected area twice daily (morning and night), or as directed by a doctor.
  • Supervise children in the use of the product.
  • If the condition persists longer, consult a doctor.
Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

If irritation occurs or there is no improvement within 4 weeks.

Section 50567-7 (50567-7)

avoid contact with eyes. If contact occurs, rinse the eyes thoroughly with water.

keep out of the reach of Children.

Section 50570-1 (50570-1)

it on children under 2 years of age unless directed by a doctor.

Section 51727-6 (51727-6)

Water, Dimethicone, Mineral Oil, Petrolatum, Glycerin, Glyceryl Monostearate, Glyceryl Stearate, PEG-100 Stearate, Stearic Acid, Rhinacanthus nasutus Leaf, Viola philippica Whole, Euphorbia hirta Whole, Murraya paniculata Whole, Mentha haplocalyx Oil, Borneol, Sophora flavescens Root, Cnidium monnieri Fruit, Bassia scoparia Whole, Dictamnus dasycarpus Root Bark, Smilax glabra Tuber, Dianthus superbus Flowering Top, Chlorhexidine Acetate

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

contact us at [email protected]

Section 55105-1 (55105-1)

Anti-fungal

Section 55106-9 (55106-9)

Miconazole Nitrate 1.5%

Section 60561-8 (60561-8)
  • Store at 59-85 ºF(15-30 ºC)
  • Close the cap tightly after use

Advanced Ingredient Data


Raw Label Data

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