MEDLINE- ethyl alcohol gel 
Medline Industries, LP

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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216 Medline 62% Antiseptic Hand Rub

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

When using this product

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

Stop use and ask a doctor

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

Keep out of reach of children.

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

Directions

  • apply to clean dry hands.
  • 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/C10-20 alkyl acrylate crosspolymer, diisopropanolamine 85%, PPG-20 methyl glucose ether, water

Package Label

8 oz

MEDLINE 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-216
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
DIISOPROPANOLAMINE (UNII: 0W44HYL8T5)  
PPG-20 METHYL GLUCOSE ETHER (UNII: 3WV1T97D3K)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53329-216-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product11/01/202012/31/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E11/01/202012/31/2022
Labeler - Medline Industries, LP (025460908)
Registrant - Medline Industries, LP (025460908)

Revised: 2/2023
Document Id: f4203ee6-1d78-636f-e053-2a95a90a0c0e
Set id: adf6d7d8-6923-25d1-e053-2a95a90a00e5
Version: 5
Effective Time: 20230207
 
Medline Industries, LP