HAND SANITIZER- alcohol gel 
Mr Knox LLP.

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 Gel

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antimicrobial

Purpose

Antimicrobial, Hand Sanitizer

Use

For handwashing to decrease bacteria on the skin.

Recommended for repeated use.

Warnings

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

When using this product keep away from eyes. In case of eye contact, rinse eyes with water.

Stop use and ask a doctor if redness and irritation develops. If issues persist, seek medical attention.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if redness and irritation develops. If issues persist, seek medical attention.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

Aqua (Water, Eau), Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Limon (Lemon) Peel Oil, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol

Package Label - Principal Display Panel

100 mL NDC: 78831-701-01

Hand Sanitizer Gel 100ml

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78831-701
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78831-701-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - Mr Knox LLP. (117547167)

Revised: 6/2020
Document Id: a7977909-56cd-25b4-e053-2995a90aac02
Set id: a7977909-56db-25b4-e053-2995a90aac02
Version: 1
Effective Time: 20200608
 
Mr Knox LLP.