APLICARE EXCEL AP- povidone-iodine and isopropyl alcohol solution 
Aplicare Products, LLC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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0039 Aplicare ExCel AP

Isopropyl alcohol

Povidone-iodine

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

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

When using this product keep out of the eyes

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

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

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

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

800 760-3236

Monday-Friday

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

52380-0039 ExCel A

ExCel AP

Povidone-Iodine

Antiseptic

NON-STERILE Solution

APLICARE EXCEL AP 
povidone-iodine and isopropyl alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52380-0039
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE7.5 mg  in 1 mL
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL720 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52380-0039-97 mL in 1 PACKET; Type 0: Not a Combination Product06/01/200405/01/2020
2NDC:52380-0039-43 mL in 1 PACKET; Type 0: Not a Combination Product06/01/200408/01/2017
3NDC:52380-0039-83 mL in 1 PACKET; Type 0: Not a Combination Product06/01/200405/01/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/01/200405/01/2020
Labeler - Aplicare Products, LLC. (081054904)
Establishment
NameAddressID/FEIBusiness Operations
Aplicare Products, LLC.081054904manufacture(52380-0039)

Revised: 2/2020
 
Aplicare Products, LLC.