Storage and handling
Other information store between 2 o and 30 o C (30 o and 86 o F) Lot No. and Exp. Date: see box or see crimp of tube
Other information store between 2 o and 30 o C (30 o and 86 o F) Lot No. and Exp. Date: see box or see crimp of tube
Active Ingredient
Clotrimazole 1%
Purpose
Antifungal
Uses
Warnings
Do not use on children under 2 years of age except under the advice and supervision of a doctor.
For external use only.
When using this product avoid contact with the eyes.
Stop use and ask a doctor if
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Other information
store between 2o and 30o C (30o and 86o F) Lot No. and Exp. Date: see box or see crimp of tube
Inactive ingredients
benzyl alcohol, isopropyl myristate, liquid parafin, polysorbate 60, propylene glycol, purified water, stearic acid, stearyl aclohol, sorbitan monostearate
Questions?
Call 1-800-645-3867, Mon-Fri 8:30 AM - 5:30 PM.
| Class | Version | Type | Effective |
|---|---|---|---|
| CLOTRIMAZOLE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| b64d2752-34ef-378a-1f4f-8bff32b0d1ae | Product name | 4 | 20250626 |
| cb7783e0-feaa-7e56-fb3b-d43b6efa77c9 | Product name | 2 | 20250121 |
| f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6 | Product name | 2 | 20151106 |
| f5395dd2-4395-d8c6-3477-8c2d4a2f951c | Product name | 1 | 20140508 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 51852-103-01 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-cf3e-8e05-e053-dbdaa90a074a | LIFElabs, a Division of Atico International USA, INC. |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51852-103-01 | Clotrimazole | 28 g in 1 TUBE | CREAM | 28 | 6 | |
| 51852-103-01 | Clotrimazole | 1 in 1 BOX | CREAM | 1 | 6 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Clotrimazole | ACTIVE INGREDIENT | G07GZ97H65 | 6 | |
| Clotrimazole | ACTIVE MOIETY | G07GZ97H65 | 6 | |
| Benzyl Alcohol | INACTIVE INGREDIENT | LKG8494WBH | 6 | |
| Isopropyl Myristate | INACTIVE INGREDIENT | 0RE8K4LNJS | 6 | |
| Mineral Oil | INACTIVE INGREDIENT | T5L8T28FGP | 6 | |
| Polysorbate 60 | INACTIVE INGREDIENT | CAL22UVI4M | 6 | |
| Propylene Glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | 6 | |
| Sorbitan Monostearate | INACTIVE INGREDIENT | NVZ4I0H58X | 6 | |
| Stearic Acid | INACTIVE INGREDIENT | 4ELV7Z65AP | 6 | |
| Stearyl Alcohol | INACTIVE INGREDIENT | 2KR89I4H1Y | 6 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | 6 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 51852-103 | 51852-103-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Clotrimazole | G07GZ97H65 | ACTIB |
| Benzyl Alcohol | LKG8494WBH | IACT |
| Isopropyl Myristate | 0RE8K4LNJS | IACT |
| Mineral Oil | T5L8T28FGP | IACT |
| Polysorbate 60 | CAL22UVI4M | IACT |
| Propylene Glycol | 6DC9Q167V3 | IACT |
| Water | 059QF0KO0R | IACT |
| Stearic Acid | 4ELV7Z65AP | IACT |
| Stearyl Alcohol | 2KR89I4H1Y | IACT |
| Sorbitan Monostearate | NVZ4I0H58X | IACT |
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 |
|---|---|---|---|---|---|---|
| Isopropyl Myristate | ISOPROPYL MYRISTATE | 0RE8K4LNJS | FILM / TRANSDERMAL | 58.08 mg | ||
| Stearyl Alcohol | STEARYL ALCOHOL | 2KR89I4H1Y | POWDER / ORAL | 0.11 mg | ||
| Benzyl Alcohol | BENZYL ALCOHOL | LKG8494WBH | CAPSULE, EXTENDED RELEASE / ORAL | 1.23 mg | ||
| Benzyl Alcohol | BENZYL ALCOHOL | LKG8494WBH | GEL / RECTAL | 124 mg | ||
| Mineral Oil | MINERAL OIL | T5L8T28FGP | FILM, EXTENDED RELEASE / TRANSDERMAL | 34 mg | ||
| Mineral Oil | MINERAL OIL | T5L8T28FGP | SUSPENSION / OPHTHALMIC | 0.1 %w/w | ||
| Benzyl Alcohol | BENZYL ALCOHOL | LKG8494WBH | TABLET, DELAYED RELEASE / ORAL | 2.31 mg | ||
| Benzyl Alcohol | BENZYL ALCOHOL | LKG8494WBH | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 144 mg | ||
| Isopropyl Myristate | ISOPROPYL MYRISTATE | 0RE8K4LNJS | GEL / TOPICAL | 29 mg | ||
| Benzyl Alcohol | BENZYL ALCOHOL | LKG8494WBH | SPRAY / NASAL | 5 mg | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | TABLET, ORALLY DISINTEGRATING / ORAL | 10 mg | ||
| Polysorbate 60 | POLYSORBATE 60 | CAL22UVI4M | EMULSION / ORAL | 20 mg/1ml | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / TOPICAL | 4886 mg | ||
| Isopropyl Myristate | ISOPROPYL MYRISTATE | 0RE8K4LNJS | SYSTEM / TRANSDERMAL | 113 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | FILM, SOLUBLE / BUCCAL | 5 mg | ||
| Sorbitan Monostearate | SORBITAN MONOSTEARATE | NVZ4I0H58X | LOTION / TOPICAL | 89 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 63.4 %w/v | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL / TOPICAL | 19.2 %w/w | ||
| Mineral Oil | MINERAL OIL | T5L8T28FGP | TABLET / ORAL | 113.75 mg | ||
| Benzyl Alcohol | BENZYL ALCOHOL | LKG8494WBH | LOTION / TOPICAL | 4000 mg | ||
| Benzyl Alcohol | BENZYL ALCOHOL | LKG8494WBH | INJECTION, SOLUTION / INTRAVENOUS | 400 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, EXTENDED RELEASE / ORAL | 8 mg | ||
| Benzyl Alcohol | BENZYL ALCOHOL | LKG8494WBH | INJECTION, EMULSION / INTRAMUSCULAR | 225 mg | ||
| Sorbitan Monostearate | SORBITAN MONOSTEARATE | NVZ4I0H58X | SUPPOSITORY / VAGINAL | NA | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION, SOLUTION / SUBCUTANEOUS | 1.4 %w/v | ||
| Benzyl Alcohol | BENZYL ALCOHOL | LKG8494WBH | SUSPENSION / TOPICAL | 1 %w/w | ||
| Polysorbate 60 | POLYSORBATE 60 | CAL22UVI4M | SHAMPOO / TOPICAL | 14.55 %w/w | ||
| Benzyl Alcohol | BENZYL ALCOHOL | LKG8494WBH | SOLUTION / INTRAVENOUS | 242 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, FOAM / RECTAL | 1214 mg | ||
| Isopropyl Myristate | ISOPROPYL MYRISTATE | 0RE8K4LNJS | OIL / TOPICAL | 213 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | CREAM / VAGINAL | 1225 mg | ||
| Sorbitan Monostearate | SORBITAN MONOSTEARATE | NVZ4I0H58X | CREAM / TOPICAL | 177 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / VAGINAL | 750 mg | ||
| Benzyl Alcohol | BENZYL ALCOHOL | LKG8494WBH | SOLUTION / TOPICAL | 2 %w/w | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SHAMPOO, SUSPENSION / TOPICAL | 2 %w/w | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | TABLET / BUCCAL | 6 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 19 mg | ||
| Polysorbate 60 | POLYSORBATE 60 | CAL22UVI4M | GUM, CHEWING / BUCCAL | 5 mg | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | LOTION / TOPICAL | 80 mg | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | AEROSOL, FOAM / TOPICAL | 8 %w/w | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED / ORAL | 176 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT, AUGMENTED / TOPICAL | 714 mg | ||
| Benzyl Alcohol | BENZYL ALCOHOL | LKG8494WBH | SOLUTION / ORAL | 360 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SWAB / TOPICAL | 34.6 %w/w | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION / INTRAVENOUS | 16624 mg | ||
| Stearyl Alcohol | STEARYL ALCOHOL | 2KR89I4H1Y | CAPSULE, EXTENDED RELEASE / ORAL | 72 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SHAMPOO / TOPICAL | 8 %w/w | ||
| Benzyl Alcohol | BENZYL ALCOHOL | LKG8494WBH | INJECTION / SUBCONJUNCTIVAL | 252 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | LIQUID / RESPIRATORY (INHALATION) | 10 %w/w | ||
| Polysorbate 60 | POLYSORBATE 60 | CAL22UVI4M | AEROSOL, FOAM / TOPICAL | 30 mg | ||
| Benzyl Alcohol | BENZYL ALCOHOL | LKG8494WBH | SUSPENSION / ORAL | 100 mg | ||
| Stearyl Alcohol | STEARYL ALCOHOL | 2KR89I4H1Y | SUPPOSITORY / VAGINAL | 8.5 mg | ||
| Mineral Oil | MINERAL OIL | T5L8T28FGP | SOAP / TOPICAL | 0.82 %w/w | ||
| Stearyl Alcohol | STEARYL ALCOHOL | 2KR89I4H1Y | TABLET, EXTENDED RELEASE / ORAL | 244 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / RECTAL | 3315 mg | ||
| Benzyl Alcohol | BENZYL ALCOHOL | LKG8494WBH | INJECTION / ENDOTRACHEAL | 54 mg | ||
| Isopropyl Myristate | ISOPROPYL MYRISTATE | 0RE8K4LNJS | CREAM / VAGINAL | 50 mg | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | AEROSOL, FOAM / VAGINAL | 4 %w/w | ||
| Benzyl Alcohol | BENZYL ALCOHOL | LKG8494WBH | INJECTION, SOLUTION / INTRA-ARTICULAR | 23 mg | ||
| Mineral Oil | MINERAL OIL | T5L8T28FGP | LOTION / TOPICAL | 1428 mg |
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 |
|---|---|---|---|---|---|---|
| a523aa80-9557-40c6-b522-00471cdf364c | bca482ac-4b65-450e-bc27-c50af9cd0416 | 2010-08-23 | Warnings | a523aa80-9557-40c6-b522-00471cdf364c bca482ac-4b65-450e-bc27-c50af9cd0416 |
Adverse event summaries are temporarily unavailable. Other product information remains available.