APLICARE ANTISEPTIC HAND RINSE- ethanol gel 
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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0540 Aplicare Antiseptic Hand Rinse

Active ingredient

Alcohol denat. (anhydrous) 62%

Purpose

Antiseptic

Use

instant hand antiseptic

Warnings

For external use only. Keep out of eyes. If contact with eyes occurs, rinse promptly and thoroughly with water.

Flammable. Keep away from fire or flame.

Stop use and ask a doctor if

significant irritation or sensitization ocurs

Keep out of reach of children.

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

Directions

Other information

Inactive ingredients

acrylates/C10-30 alkyl acrylate crosspolymer, diisopropanolamine, FD&C blue no. 1, FD&C yellow no. 5, fragrance, PPG-20 methyl, glucose ether, water

Questions or comments?

1 800 633-5463

Manufacturing Information

Manufactured by:

Aplicare Products, LLC

550 Research Parkway, Meriden, CT 06450 USA

Made in USA

REF: APLL1540

RJ19APL

Package Label

Label Front

Label Back

APLICARE ANTISEPTIC HAND RINSE 
ethanol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52380-0540
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.62 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIISOPROPANOLAMINE (UNII: 0W44HYL8T5)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52380-0540-11.5 mL in 1 PACKET; Type 0: Not a Combination Product02/14/201807/31/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/01/200607/31/2025
Labeler - Aplicare Products, LLC (081054904)
Registrant - Medline Industries, LP (025460908)

Revised: 12/2022
Document Id: efe327ce-23aa-60a6-e053-2a95a90abf12
Set id: fcf08e5a-7212-4b06-a93c-34425e7a5b7e
Version: 11
Effective Time: 20221215
 
Aplicare Products, LLC