FDA.reportPublic FDA data

SKIN REPAIR

Manufacturer
Zhejiang Shiao Technology Co., Ltd.
Effective date
2020-04-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:08:10

Label at a glance#

ProductSKIN REPAIR
Active ingredientCLOTRIMAZOLE
Label structure8 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

30ML, 3-5 sprays each time, twice a day

WARNINGS SECTION

For external use only, Do not swallow When using this product
Keep out of eyes, ears, and mouth. If contact occurs, rinse with plenty of cold water right away and contact a physician. If swallowing, drink plenty of water and contact a physician
Please consult a doctor, if you have serious wounds, severe burns or animal bites.
Do not use this product if you are allergic to it.

INACTIVE INGREDIENT SECTION

WATER
METHANOL
ISOPROPYL ALCOHOL
N,N-DIMETHYLOCTADECYL AMINE
PROPYLENE GLYCOL, (S)-
PROPYLENE CARBONATE

BENZETHONIUM CHLORIDE

QUATERNIUM-16

OTC - ACTIVE INGREDIENT SECTION

CLOTRIMAZOLE

INDICATIONS & USAGE SECTION

Hold the spray bottle (do not turn it upside down) withthe spray nozzle 10- 15cm away from the surface of the infectedarea, andspray evenly as far as possible, 3-5 sprays each time, twice a day, andspray on contacting object (if any)once a day. Each dose can be increased or decreased according to the actual situation of the patient. In severe cases, 10-15 sprays are recommended until the acute inflammation or major symptoms disappear.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

OTC - PURPOSE SECTION

This product can be used for anti-inflammatory debridement of wounds, and treatment of hair folliculitis, pustule sores, and jock itches caused by bacterial infection. It can also cooperate to treat beriberi, and cut off the source of infection by spraying on shoes and socks.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CLOTRIMAZOLE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130782901868735GTIN-13: 0782901868735
EAN-13: 0782901868735
GTIN-12: 782901868735
UPC-A: 782901868735
GTIN storage (14 digits): 00782901868735		label.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b64d2752-34ef-378a-1f4f-8bff32b0d1aeProduct name420250626
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9Product name220250121
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55451-010-012022-01-28C16284748780-1d6a99b39-8a86-a426-e053-dadaa90af4c2a4414bb7-2275-251b-e053-2995a90aa93a

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55451-010-01SKIN REPAIR30 mL in 1 BOTTLESPRAY301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55451-010SKIN REPAIR (CLOTRIMAZOLE) SPRAY [ZHEJIANG SHIAO TECHNOLOGY CO., LTD.]1Legacy NDC, 1 package rows20200427_a4414bb7-2275-251b-e053-2995a90aa93a.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55451-01055451-010-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZETHONIUM CHLORIDEPH41D05744IACT
QUATERNIUM-16K4H0FG9I2TIACT
WATER059QF0KO0RIACT
PROPYLENE CARBONATE8D08K3S51EIACT
CLOTRIMAZOLEG07GZ97H65ACTIB
METHYL ALCOHOLY4S76JWI15IACT
ISOPROPYL ALCOHOLND2M416302IACT
DYMANTHINE066975NG22IACT
PROPYLENE GLYCOL, (S)-942194N4TDIACT

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a4414bb7-2276-251b-e053-2995a90aa93aa4414bb7-2275-251b-e053-2995a90aa93a2020-04-27WarningsExact identifier
spl id: a4414bb7-2276-251b-e053-2995a90aa93a
spl set id: a4414bb7-2275-251b-e053-2995a90aa93a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.