1738 Aplicare Povidone Iodine Gel, 10%

Manufacturer
Aplicare Products, LLC | Medline Industries, LP
Effective date
2021-12-01
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 22:25:11

Label at a glance#

ProductAplicare Povidone Iodine
Active ingredientPOVIDONE-IODINE
Label structure10 sections

Dosage and administration

apply locally as needed

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Povidone-iodine 10%

(equivalent to 1% available iodine)

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

  • • antiseptic skin preparation
  • • single use when used for patient preoperative skin preparation

Warnings

WARNINGS SECTION

  • For external use only
  • Avoid "pooling" beneath patient. Prolonged exposure to wet solution may cause skin irritation.

Do not use

OTC - DO NOT USE SECTION

  • • in the eyes
  • • on individuals allergic or sensitive to iodine

Ask a doctor before use if injuries are

OTC - ASK DOCTOR SECTION

  • • deep or puncture wounds
  • • serious burns

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • • redness, irritation, swelling or pain persists or increases
  • • infection occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

apply locally as needed

Other information

OTHER SAFETY INFORMATION

  • • not made with natural rubber latex
  • • for hospital or professional use only

Inactive ingredients

INACTIVE INGREDIENT SECTION

disodium phosphate, glycerin, hydroxyethylcellulose, nonoxynol-10, simethicone, water

Questions or comments?

OTC - QUESTIONS SECTION

1-800-633-5463

Manufacturing Information

SPL UNCLASSIFIED SECTION

Manufactured by:

Aplicare Products, LLC

550 Research Parkway, Meriden, CT 06540 USA

Made in USA

REF: APL82-269

RL17HND

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52380-1738-4ML - Milliliter52380-173881a22634-5bde-4b58-9222-4ee453db4ddf22013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99M4
IODINEACTIVE MOIETY9679TC07X44
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O4
GLYCERININACTIVE INGREDIENTPDC6A3C0OX4
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)INACTIVE INGREDIENTS38J6RZN164
NONOXYNOL-10INACTIVE INGREDIENTK7O76887AP4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU44
SODIUM PHOSPHATE, DIBASIC ANHYDROUSINACTIVE INGREDIENT22ADO53M6F4
WATERINACTIVE INGREDIENT059QF0KO0R4

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52380-173852380-1738-4, 52380-1738-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML · Source PDF

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 4 · 187 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, CHEWABLE, EXTENDED RELEASE / ORAL2 mgExact identifier — unii candidate
49 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FTABLET, FOR SUSPENSION / ORAL60 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, SOLUTION / INTRAVENOUS2460 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, SUSPENSION / INTRAMUSCULAR36 mgExact identifier — unii candidate
48 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SUSPENSION / SUBCUTANEOUS1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16SOLUTION / TOPICAL0.21 %w/vExact identifier — unii candidate
15 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / TRANSDERMAL306.2 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR1751 mgExact identifier — unii candidate
48 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GRANULE, DELAYED RELEASE / ORAL3.2 mgExact identifier — unii candidate
49 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FSPRAY / NASAL1 mgExact identifier — unii candidate
48 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4POWDER / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE, LIQUID FILLED / ORAL106 mgExact identifier — unii candidate
49 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE, COATED / ORAL3 mgExact identifier — unii candidate
49 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FOINTMENT / TOPICAL1 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR139.2 mgExact identifier — unii candidate
48 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / OPHTHALMIC6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / NASAL10 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, SUSPENSION / INTRA-ARTICULAR36 mgExact identifier — unii candidate
48 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / NASAL25 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION / INTRAMUSCULAR1751 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, SUSPENSION / INTRASYNOVIAL3 mgExact identifier — unii candidate
48 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4FILM, EXTENDED RELEASE / TRANSDERMAL49 mgExact identifier — unii candidate
49 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / SUBCUTANEOUS450 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / VAGINALNAExact identifier — unii candidate
75 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / VAGINAL8 %w/wExact identifier — unii candidate
49 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / DENTAL15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXEMULSION / OPHTHALMIC3 mgExact identifier — unii candidate
75 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
49 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, SOLUTION / SUBCUTANEOUS0.11 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FTABLET / ORAL96 mgExact identifier — unii candidate
48 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4FILM, SOLUBLE / ORAL2 mgExact identifier — unii candidate
49 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16SYRUP / ORAL2 mg/5mlExact identifier — unii candidate
15 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSHAMPOO / TOPICAL5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4SUSPENSION, EXTENDED RELEASE / ORAL70 mgExact identifier — unii candidate
49 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TAMPON / VAGINALNAExact identifier — unii candidate
49 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / OPHTHALMIC0.88 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16GEL / TOPICAL4 mgExact identifier — unii candidate
15 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / ORAL26208 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAMUSCULAR450 mgExact identifier — unii candidate
75 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GRANULE, FOR SUSPENSION / ORAL200 mgExact identifier — unii candidate
49 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / OPHTHALMIC12 mgExact identifier — unii candidate
75 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16SPRAY / NASAL0.1 mg/0.2mlExact identifier — unii candidate
15 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FSOLUTION / INTRAVENOUS381 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FAEROSOL, FOAM / TOPICAL0.09 %w/wExact identifier — unii candidate
48 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXMOUTHWASH / BUCCAL100 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION / INTRAVENOUS381 mgExact identifier — unii candidate
48 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / TOPICAL6 mgExact identifier — unii candidate
49 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / VAGINAL60 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, EMULSION / INTRAVENOUS0.28 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16SUSPENSION / ORAL100 mgExact identifier — unii candidate
15 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / TOPICAL18144 mgExact identifier — unii candidate
75 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16SUSPENSION / TOPICAL0.69 %w/vExact identifier — unii candidate
15 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16TABLET, EXTENDED RELEASE / ORAL350 mgExact identifier — unii candidate
15 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / ORAL750 mgExact identifier — unii candidate
75 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
49 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, SOLUTION / INTRATHECAL1 mgExact identifier — unii candidate
48 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
d2195149-8a70-1445-e053-2995a90aec963a7874fb-e664-4e2c-b453-1aeee4832add2021-12-01WarningsExact identifier
spl id: d2195149-8a70-1445-e053-2995a90aec96
spl set id: 3a7874fb-e664-4e2c-b453-1aeee4832add

Reported adverse events (FAERS/openFDA)#

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