APLICARE ANTISEPTIC HAND RINSE- ethanol gel

Aplicare Antiseptic Hand Rinse by

Drug Labeling and Warnings

Aplicare Antiseptic Hand Rinse by is a Otc medication manufactured, distributed, or labeled by Aplicare Products, LLC., Medline Industries, LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Ethyl alcohol 62% v/v

Purpose

Antiseptic

Uses

• health care personnel rub to help reduce bacteria that potentially can cause disease
• recommended for repeated use

Warnings

For external use only. Flammable. Keep away from heat or flame.

Do not use

• in children less than 2 months of age
• on open skin wounds

Stop use and ask a doctor

if irritation or rash occurs. These may be signs of a serious condition.

When using this product

keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Wet hands thoroughly with product and allow to dry without wiping
  

Other information

• not made with natural rubber latex
• store between 15-30°C (59-86°F)
• avoid freezing and excessive heat above 40°C (104°F)

Inactive ingredients

acrylates/C10-30 alkyl acrylate crosspolymer, diisopropanolamine, PPG-20 methyl glucose ether, water

Manufacturing information

Manufactured by: Aplicare Products, LLC

550 Research Parkway, Meriden, CT 06450 USA

Made in USA

Principal Display Panel

INGREDIENTS AND APPEARANCE

APLICARE ANTISEPTIC HAND RINSE 
ethanol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52380-1614
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
PPG-20 METHYL GLUCOSE ETHER (UNII: 3WV1T97D3K)
WATER (UNII: 059QF0KO0R)
DIISOPROPANOLAMINE (UNII: 0W44HYL8T5)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52380-1614-2	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/20/2018	07/01/2020
2	NDC: 52380-1614-4	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/20/2018	07/01/2020
3	NDC: 52380-1614-6	480 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/20/2018	07/01/2020
4	NDC: 52380-1614-0	1.5 mL in 1 PACKET; Type 0: Not a Combination Product	02/20/2018	07/01/2020
5	NDC: 52380-1614-3	360 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/20/2018	07/01/2020
6	NDC: 52380-1614-9	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/31/2020
7	NDC: 52380-1614-5	189271 mL in 1 DRUM; Type 0: Not a Combination Product	03/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/01/1998

Labeler - Aplicare Products, LLC. (081054904)

Establishment
Name	Address	ID/FEI	Business Operations
Aplicare Products, LLC.		081054904	manufacture(52380-1614)