FDA.reportPublic FDA data

Aplicare ExCel AP

Manufacturer
Aplicare Products, LLC.
Effective date
2020-02-03
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
legacy-cache
Hydrated at
2026-08-01 23:42:00

Label at a glance#

ProductAplicare ExCel AP
Active ingredientPOVIDONE-IODINE, ISOPROPYL ALCOHOL
Label structure13 sections

Indications and uses

for preparation of the skin prior to injection helps reduce bacteria that can potentially cause skin infection

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Isopropyl alcohol

Povidone-iodine

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • for preparation of the skin prior to injection
  • helps reduce bacteria that can potentially cause skin infection

Warnings

WARNINGS SECTION

Flammable

  • keep away from fire or flame
  • do not use with electrocautery devices

For external use only

OTC - DO NOT USE SECTION

D o not use on patients with known allergies to iodine or isopropyl alcohol

OTC - WHEN USING SECTION

When using this product keep out of the eyes

OTC - STOP USE SECTION

Stop use and consult a physician if

  • redness, irritation or swelling occurs
  • condition persists for more than 72 hours
  • infection occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

DOSAGE & ADMINISTRATION SECTION

Directions

For preparation for dry sites such as abdomen, chest or arm

  • open package at tear notch
  • scrub with repeated back and forth motion for 10 seconds
  • allow prepped area to completely air dry

Other information

OTHER SAFETY INFORMATION

  • store between 15-25°C (59-77°F)
  • avoid freezing and excessive heat
  • latex free
  • for hospital or professional use only

INACTIVE INGREDIENT SECTION

acrylates/steareth-20 methacrylate copolymer, aminomethyl propanol, phosphoric acid, purified water

OTC - QUESTIONS SECTION

For questions, comments, or to report serious side effects:

800 760-3236

Monday-Friday

8:30 a.m. - 5:00 p.m. EST

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

52380-0039 ExCel A52380-0039 ExCel A

ExCel AP

Povidone-Iodine

Antiseptic

NON-STERILE Solution

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52380-0039-42020-02-03C16284748780-19d75b9d0-3c94-f424-e053-dadaa90a57ce0039 Aplicare ExCel AP
52380-0039-82020-02-03C16284748780-19d75b9d0-3c94-f424-e053-dadaa90a57ce0039 Aplicare ExCel AP
52380-0039-92020-02-03C16284748780-19d75b9d0-3c94-f424-e053-dadaa90a57ce0039 Aplicare ExCel AP
52380-0039-42020-01-31C16284748780-19d75b9d0-3c94-f424-e053-dadaa90a57ce0039 Aplicare ExCel AP
52380-0039-82020-01-31C16284748780-19d75b9d0-3c94-f424-e053-dadaa90a57ce0039 Aplicare ExCel AP
52380-0039-92020-01-31C16284748780-19d75b9d0-3c94-f424-e053-dadaa90a57ce0039 Aplicare ExCel AP

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52380-0039-4EA - Each52380-0039e561d835-62e1-4996-8b35-64d42fdd553512012-07-24
52380-0039-9EA - Each52380-0039597bfe0a-a888-4628-9535-33476ea7150312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ISOPROPYL ALCOHOLACTIVE INGREDIENTND2M4163029
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99M9
IODINEACTIVE MOIETY9679TC07X49
ISOPROPYL ALCOHOLACTIVE MOIETYND2M4163029
AMINOMETHYLPROPANOLINACTIVE INGREDIENTLU49E6626Q9
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NN9
WATERINACTIVE INGREDIENT059QF0KO0R9

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52380-003952380-0039-9, 52380-0039-4, 52380-0039-8

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
PHOSPHORIC ACIDE4GA8884NNIACT
POVIDONE-IODINE85H0HZU99MACTIM
ISOPROPYL ALCOHOLND2M416302ACTIB

Source Document#

Source XML

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.

Inactive ingredient links page 1 of 1 · 30 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNSPONGE / TOPICALADJ PHExact identifier — unii candidate
28 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNCREAM / VAGINAL0.56 %w/wExact identifier — unii candidate
28 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNTABLET, EXTENDED RELEASE / ORAL0.19 mgExact identifier — unii candidate
28 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNTABLET / ORAL0.04 mgExact identifier — unii candidate
28 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNSOLUTION / ORAL19 mgExact identifier — unii candidate
28 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNINJECTION / SOFT TISSUEADJ PHExact identifier — unii candidate
28 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNINJECTION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
28 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNCREAM / TOPICAL13 mgExact identifier — unii candidate
28 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNLOTION, AUGMENTED / TOPICAL1 mgExact identifier — unii candidate
28 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNINJECTION, POWDER, FOR SOLUTION / INTRAVENOUSADJ PHExact identifier — unii candidate
28 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUSADJ PHExact identifier — unii candidate
28 equally ranked IID candidates
AMINOMETHYLPROPANOLAMINOMETHYLPROPANOLLU49E6626QLOTION / TOPICAL0.3 %w/wExact identifier — unii candidate
2 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNGEL / TOPICALADJ PHExact identifier — unii candidate
28 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNSOLUTION / TOPICAL0.23 %w/wExact identifier — unii candidate
28 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNPASTE, DENTIFRICE / DENTALADJ PHExact identifier — unii candidate
28 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNINJECTION, SOLUTION / INTRAVENOUSADJ PHExact identifier — unii candidate
28 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNINJECTION / INTRALESIONALADJ PHExact identifier — unii candidate
28 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULARADJ PHExact identifier — unii candidate
28 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNTABLET, FILM COATED, EXTENDED RELEASE / ORAL6 mgExact identifier — unii candidate
28 equally ranked IID candidates
AMINOMETHYLPROPANOLAMINOMETHYLPROPANOLLU49E6626QCREAM / TOPICAL1 %w/wExact identifier — unii candidate
2 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNAEROSOL, FOAM / VAGINALNAExact identifier — unii candidate
28 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNINJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
28 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNINJECTION / INTRAMUSCULARADJ PHExact identifier — unii candidate
28 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNOINTMENT / TOPICALADJ PHExact identifier — unii candidate
28 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNLOTION / TOPICAL1 mgExact identifier — unii candidate
28 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNINJECTION / INTRA-ARTICULARADJ PHExact identifier — unii candidate
28 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNSOLUTION/ DROPS / OPHTHALMICADJ PHExact identifier — unii candidate
28 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNINJECTION / INTRAVENOUS1294 mgExact identifier — unii candidate
28 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNSOLUTION / OPHTHALMICADJ PHExact identifier — unii candidate
28 equally ranked IID candidates
PHOSPHORIC ACIDPHOSPHORIC ACIDE4GA8884NNTABLET, ORALLY DISINTEGRATING / ORAL4 mgExact identifier — unii candidate
28 equally ranked IID candidates

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
65a82ddc-80f9-ed37-e053-2a91aa0a62c776615174-e530-4e88-a02c-2f7d0b5a5b042018-02-20WarningsExact identifier
spl set id: 76615174-e530-4e88-a02c-2f7d0b5a5b04

Reported adverse events (FAERS/openFDA)#

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