216 Medline 62% Antiseptic Hand Rub

Medline by

Drug Labeling and Warnings

Medline by is a Otc medication manufactured, distributed, or labeled by Medline Industries, LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

MEDLINE 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53329-216
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
DIISOPROPANOLAMINE (UNII: 0W44HYL8T5)
PPG-20 METHYL GLUCOSE ETHER (UNII: 3WV1T97D3K)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53329-216-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2020	12/31/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	11/01/2020	12/31/2022

Labeler - Medline Industries, LP (025460908)

Registrant - Medline Industries, LP (025460908)

Revised: 2/2023

Document Id: f4203ee6-1d78-636f-e053-2a95a90a0c0e

34390-5

Set id: adf6d7d8-6923-25d1-e053-2a95a90a00e5

Version: 5

Effective Time: 20230207