APLICARE EXCEL AP- povidone-iodine and isopropyl alcohol solution

Aplicare ExCel AP by

Drug Labeling and Warnings

Aplicare ExCel AP by is a Otc medication manufactured, distributed, or labeled by Aplicare Products, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Isopropyl alcohol

Povidone-iodine

PURPOSE

Antiseptic

Uses

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

Warnings

Flammable

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

For external use only

DO NOT USE

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

WHEN USING

When using this product keep out of the eyes

STOP USE

Stop use and consult a physician if

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

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

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

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

INACTIVE INGREDIENT

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

QUESTIONS

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

800 760-3236

Monday-Friday

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

PRINCIPAL DISPLAY PANEL

ExCel AP

Povidone-Iodine

Antiseptic

NON-STERILE Solution

INGREDIENTS AND APPEARANCE

APLICARE EXCEL AP 
povidone-iodine and isopropyl alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52380-0039
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	7.5 mg  in 1 mL
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	720 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
PHOSPHORIC ACID (UNII: E4GA8884NN)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52380-0039-9	7 mL in 1 PACKET; Type 0: Not a Combination Product	06/01/2004	05/01/2020
2	NDC: 52380-0039-4	3 mL in 1 PACKET; Type 0: Not a Combination Product	06/01/2004	08/01/2017
3	NDC: 52380-0039-8	3 mL in 1 PACKET; Type 0: Not a Combination Product	06/01/2004	05/01/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/01/2004	05/01/2020

Labeler - Aplicare Products, LLC. (081054904)

Establishment
Name	Address	ID/FEI	Business Operations
Aplicare Products, LLC.		081054904	manufacture(52380-0039)