HAND SANITIZER- ethyl alcohol gel 
Medline Industries, Inc.

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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201 Medline 62% Hand Sanitizer

Active ingredient

Ethyl Alcohol 62%

Purpose

Antiseptic

Uses

  • To decrease bacteria on the skin that could potentially cause disease
  • recommended for repeated use.

Warnings

For external use only: hands

Flammable, keep away from fire or flame.

When using this product

  • keep out of eyes. In case of contact with eyes, flush thoroughly with water
  • Avoid contact with broken skin
  • Do not inhale or ingest.

Stop use and ask a doctor if

  • irritation or redness develop
  • condition persists for more than 72 hours.

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
  • For children under 6, use only under adult supervision
  • Not recommended for infants.

Other Information

  • Do not store above 105 F
  • May discolor some fabrics
  • Harmful to wood finishes and plastics

Inactive ingredients

Water, aloe barbadensis leaf juice, tocopheryl acetate, glycerin, carbomer, propylene glycol, isopropyl myristate

Package/Label Principal Display Panel

MEDLINE HAND SANITIZER GEL PDP AND DRUG FACTS

MEDLINE

NDC: 53329-201-70

HAND SANITIZER GEL

62% ETHYL ALCOHOL

Fragrance Free

15 FL OZ 443 mL

REF HH62G15

HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-201
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
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53329-201-1359 mL in 1 BOTTLE; Type 0: Not a Combination Product04/06/201512/31/2020
2NDC:53329-201-70443 mL in 1 BOTTLE; Type 0: Not a Combination Product04/06/201512/31/2020
3NDC:53329-201-841000 mL in 1 BAG; Type 0: Not a Combination Product04/06/201512/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E04/06/201512/31/2020
Labeler - Medline Industries, Inc. (025460908)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, Inc088520668manufacture(53329-201)

Revised: 7/2021
Document Id: c71708a8-67cf-066b-e053-2a95a90a2901
Set id: a65d6b52-8e3a-4083-abec-034589357197
Version: 3
Effective Time: 20210714
 
Medline Industries, Inc.