MEDCILLARY Hand Sanitizer by MLS 73984-329

MEDCILLARY Hand Sanitizer by

Drug Labeling and Warnings

MEDCILLARY Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by MLS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MEDCILLARY HAND SANITIZER- alcohol gel 
MLS

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.

----------

73984-329

Active ingredient

Ethyl Alcohol 70%

Purpose

Antiseptic

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

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

Do not use

on children less than 2 months of age

on open 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

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

Other information

Store between 15-30C (59-86F)

Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Water, Methylpropanediol, Sodium Hyaluronate, Aloe Barbadensis Leaf Extract, Butylene Glycol, Carbomer, Triethanolamine, 1,2-Hexanediol

Package Label

MEDCILLARY HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73984-329
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73984-329-01	80 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/12/2020	12/31/2020
2	NDC: 73984-329-02	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/12/2020	12/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/12/2020	12/31/2020

Labeler - MLS (689850283)

Registrant - MLS (689850283)

Establishment
Name	Address	ID/FEI	Business Operations
MLS		689850283	manufacture(73984-329)

Revised: 1/2021

Document Id: b936e43e-1dd1-6253-e053-2a95a90a3304

34390-5

Set id: a7f68666-da74-4efe-e053-2995a90a3c41

Version: 2

Effective Time: 20210118