Micro-Guard
- Manufacturer
- Coloplast Corp | Medline Industries, LP
- Effective date
- 2026-03-27
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 8
- Source
- full-release
- Hydrated at
- 2026-06-01 01:51:53
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
For Effective Treatment of Topical Fungal Infections
AF
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredient
Miconazole Nitrate, 2%
OTC - PURPOSE SECTION
Purpose
Antifungal
INDICATIONS & USAGE SECTION
Uses Treats jock itch, ringworm, and athlete's foot ►
WARNINGS SECTION
Warnings
For external use only.
OTC - WHEN USING SECTION
When using this product
- avoid contact with the eyes
- if eye contact occurs, flush with water
- do not use on children under 2 years of age unless directed by a doctor.
OTC - STOP USE SECTION
Stop using this product
- for athlete's foot or ringworm if irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor
- for jock itch if irritation occurs or if there is no improvement within 2 weeks, discontinue use and consult a doctor.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep this and all drugs out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
Directions
- clean the affected area and dry thoroughly
- apply over the affected area twice daily (morning and night) or as directed by a doctor
- supervise children in the use of this product.
SPL UNCLASSIFIED SECTION
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
SPL UNCLASSIFIED SECTION
For athlete's foot and ringworm
- use daily for 4 weeks
SPL UNCLASSIFIED SECTION
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.
INACTIVE INGREDIENT SECTION
Inactive ingredients corn starch USP, sodium bicarbonate, tri-calcium phosphate
Manufactured for Coloplast A/S DK-3050 Humlebaek, Denmark
Distributed by: Coloplast Corp. Minneapolis, MN 55411 U.S.A.
1-800-533-0464
www.us.coloplast.com Product #1337
©2008-11, Coloplast Corp. Made in the U.SA
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 998461 | miconazole nitrate 2 % Topical Powder | PSN | 8 |
| 998469 | Micro-Guard 2 % Topical Powder | PSN | 8 |
| 998469 | miconazole nitrate 0.02 MG/MG Topical Powder [Micro-Guard] | SBD | 8 |
| 998461 | miconazole nitrate 0.02 MG/MG Topical Powder | SCD | 8 |
| 998461 | miconazole nitrate 2 % Topical Powder | SY | 8 |
| 998469 | Micro-Guard 0.02 MG/MG Topical Powder | SY | 8 |
| 998469 | Micro-Guard 2 % Topical Powder | SY | 8 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| MICONAZOLE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| fb7ab793-2c12-4079-b100-a64f73bef25a | Product name | 4 | 20240712 |
| b0cbf770-6cc3-4aa4-9158-755110c2b9f7 | Product name | 2 | 20230717 |
| dc7c5daa-021f-40dd-b00d-63982cb2067a | Product name | 1 | 20230426 |
| 08ffbcbf-26df-b99c-1dab-64fc4cfae89f | Product name | 5 | 20200925 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 08ffbcbf-26df-b99c-1dab-64fc4cfae89f | Product name | 2 | 20160823 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| 3a55f4fb-5aec-4c88-0ff7-4d608ad4866a | Product name | 1 | 20140508 |
| 5b9a7965-36d2-8412-dcaf-f76a65411611 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 11701-038-16 | 2023-12-15 | C162847 | 48780-1 | f386c649-a446-0266-e053-dadaa90a7c1a | Micro-Guard ® Powder Antifungal Powder With Miconazole Nitrate 2% |
| 11701-038-16 | 2023-01-30 | C162847 | 48780-1 | f386c649-a446-0266-e053-dadaa90a7c1a | Micro-Guard ® Powder Antifungal Powder With Miconazole Nitrate 2% |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 11701-038-16 | Micro-Guard(AF) | 85 g in 1 BOTTLE | POWDER | 85 | 8 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 11701-038-16 | GM - Gram | 11701-038 | 5caa278f-1182-4ab9-bb46-9aa6bfb984bc | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| MICONAZOLE NITRATE | ACTIVE INGREDIENT | VW4H1CYW1K | 4 | |
| MICONAZOLE | ACTIVE MOIETY | 7NNO0D7S5M | 4 | |
| SODIUM BICARBONATE | INACTIVE INGREDIENT | 8MDF5V39QO | 4 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | 4 | |
| TRIBASIC CALCIUM PHOSPHATE | INACTIVE INGREDIENT | 91D9GV0Z28 | 4 |
Products#
Every source-derived product name is available through these pages.
- Micro-Guard (AF)
- Miconazole Nitrate
- MICONAZOLE
- STARCH, CORN
- SODIUM BICARBONATE
- TRIBASIC CALCIUM PHOSPHATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 11701-038 | 11701-038-16 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MICONAZOLE NITRATE | VW4H1CYW1K | ACTIB |
| STARCH, CORN | O8232NY3SJ | IACT |
| SODIUM BICARBONATE | 8MDF5V39QO | IACT |
| TRIBASIC CALCIUM PHOSPHATE | 91D9GV0Z28 | IACT |
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | LOZENGE / ORAL | 100 mg | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | GUM, CHEWING / ORAL | 360 mg | ||
| TRIBASIC CALCIUM PHOSPHATE | TRIBASIC CALCIUM PHOSPHATE | 91D9GV0Z28 | TABLET, CHEWABLE / ORAL | 130 mg | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | GRANULE, EFFERVESCENT / ORAL | 267 mg | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | SOLUTION / ORAL | ADJ PH | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CAPSULE, COATED, EXTENDED RELEASE / ORAL | 19 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / ORAL | 1116 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / BUCCAL | 16.6 mg | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | TABLET, COATED / ORAL | 10.6 mg | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 4 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | SUSPENSION/ DROPS / ORAL | 90 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, DELAYED RELEASE / ORAL | 713 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, EXTENDED RELEASE / ORAL | 184 mg | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | INJECTION, SOLUTION / INTRAVENOUS | 52 mg | ||
| TRIBASIC CALCIUM PHOSPHATE | TRIBASIC CALCIUM PHOSPHATE | 91D9GV0Z28 | CAPSULE, EXTENDED RELEASE / ORAL | 32.73 mg | ||
| TRIBASIC CALCIUM PHOSPHATE | TRIBASIC CALCIUM PHOSPHATE | 91D9GV0Z28 | TABLET, EXTENDED RELEASE / ORAL | 750 mg | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | TABLET / ORAL | 1300 mg | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | FILM, SOLUBLE / ORAL | 2 mg | ||
| TRIBASIC CALCIUM PHOSPHATE | TRIBASIC CALCIUM PHOSPHATE | 91D9GV0Z28 | TABLET / SUBLINGUAL | 99.2 mg | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | TABLET, EFFERVESCENT / ORAL | 57600 mg | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | INJECTION / INTRAMUSCULAR | 175 mg | ||
| TRIBASIC CALCIUM PHOSPHATE | TRIBASIC CALCIUM PHOSPHATE | 91D9GV0Z28 | TABLET / ORAL | 330 mg | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | INJECTION / INTRATHECAL | 0.05 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CAPSULE / ORAL | 5785 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | DROPS / ORAL | NA | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | SUSPENSION, EXTENDED RELEASE / ORAL | 113 mg | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | GUM, CHEWING / ORAL | 360 mg | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | TABLET, CHEWABLE / ORAL | 140 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, ORALLY DISINTEGRATING / ORAL | 100 mg | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR | ADJ PH | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 3219 mg | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 1000 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / SUBLINGUAL | 409 mg | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | TABLET / BUCCAL | 42 mg | ||
| TRIBASIC CALCIUM PHOSPHATE | TRIBASIC CALCIUM PHOSPHATE | 91D9GV0Z28 | TABLET, COATED / ORAL | 40 mg | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | TABLET / SUBLINGUAL | 6 mg | ||
| TRIBASIC CALCIUM PHOSPHATE | TRIBASIC CALCIUM PHOSPHATE | 91D9GV0Z28 | TABLET / BUCCAL | 99.2 mg | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 6 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | SUSPENSION / ORAL | 900 mg | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 3059 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CAPSULE, COATED, EXTENDED RELEASE / ORAL | 19 mg | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | INSERT / VAGINAL | 129 mg | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 4 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 21 mg | ||
| TRIBASIC CALCIUM PHOSPHATE | TRIBASIC CALCIUM PHOSPHATE | 91D9GV0Z28 | TABLET, FILM COATED / ORAL | 21.8 mg | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS | 160 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CAPSULE, DELAYED RELEASE / ORAL | 216 mg | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS | 160 mg | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | TABLET / BUCCAL | 42 mg | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | SOLUTION / RESPIRATORY (INHALATION) | 2 %w/w | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR | ADJ PH | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | TABLET, CHEWABLE / ORAL | 140 mg | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | TABLET, COATED / ORAL | 10.6 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, CHEWABLE / ORAL | 180 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / BUCCAL | 16.6 mg | ||
| TRIBASIC CALCIUM PHOSPHATE | TRIBASIC CALCIUM PHOSPHATE | 91D9GV0Z28 | TABLET, COATED / ORAL | 40 mg | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | TABLET, FILM COATED / ORAL | 86 mg | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | TABLET, DELAYED RELEASE / ORAL | 30 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, CHEWABLE / ORAL | 180 mg | ||
| TRIBASIC CALCIUM PHOSPHATE | TRIBASIC CALCIUM PHOSPHATE | 91D9GV0Z28 | CAPSULE, EXTENDED RELEASE / ORAL | 32.73 mg |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Micro-Guard (AF) | MICONAZOLE NITRATE | Coloplast Corp | a43a94d0-fec0-470f-bdb4-535dcce6d1e0 | 2026-03-27 | Warnings | 11701-038-16 11701-038 11701003816 ecd660df-c2f6-4a4c-b878-4451869d9770 a43a94d0-fec0-470f-bdb4-535dcce6d1e0 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
