HAND SANITIZER- alcohol gel 
Nuance Medical, LLC

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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Hand Sanitizer

Drug Facts

Active ingredient

Ethyl Alcohol 62.5% v/v

Purposes

Antiseptic handwash

Uses

for handwashing to decrease bacteria on the skin

Warnings

Do not use

  • In eyes| In children less than 2 months of ag| on open skin wounds

When using this product

  • If in eyes, rinse promptly and thoroughly with water
  • Discontinue use if irritation and redness develops

Stop use and ask a doctor if skin irritation or redness occurs or 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

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children 6 years of age when using this product to avoid swallowing

Other Information

Inactive Ingredients

water (aqua), propylene glycol, dimethicone PEG-7 Isostearate, acrylates/ C10-30 Alkyl Acrylate Crosspolymer, aminomethylpropanediol, tocopherol acetate, aloe barbadensis leaf juice

PRINCIPAL DISPLAY PANEL - 177.4 ml Bottle Label

Nuance Medical®

HAND SANITIZER
GEL

ANTISEPTIC | RINSE-FREE | 62.5% ALCOHOL

FOR HANDS
Dye Free, Fragrance Free

Kills 99.99% of germs and
Bacteria in just 15 seconds

6 fl. oz. (177.4 ml)

Made in USA

Item # G180060

Principal Display Panel - 177.4 ml Bottle Label
HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74318-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62.5 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Propylene Glycol (UNII: 6DC9Q167V3)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
DIMETHICONE PEG-8 ISOSTEARATE (UNII: JGV7463UFN)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
Tocopherol (UNII: R0ZB2556P8)  
Aloe Vera Leaf (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74318-100-06177 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/04/2020
2NDC:74318-100-16473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/04/2020
3NDC:74318-100-32946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/04/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart333E04/01/2020
Labeler - Nuance Medical, LLC (078797666)

Revised: 7/2021
Document Id: 5f177eb1-2658-4c73-926a-087de5032860
Set id: 8d7a383c-a863-4141-9ece-ea8a8ded9d50
Version: 2
Effective Time: 20210714
 
Nuance Medical, LLC