HAND SANITIZER- alcohol gel 
Noble Roots, 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 70% v/v

Purpose

Antimicrobial

Use

Hand sanitizer to help reduce bacteria on the skin

Warnings

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

Do not use

  • on 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.

Discontinue use if irritation or redness develops. If condition persists for more than 72 hours, consult a doctor.

Keep out of reach of children.

If swallowed, get medical help or call a poison control center immediately.

Directions

Other information

Inactive ingredients

Water, Glycerin, Hydroxyethylcellulose, Aloe Barbadensis Leaf Juice, Citric Acid, Sodium Hydroxide

Questions?

678-897-4758

Distributed by:
Noble Roots LLC
Lawrenceville, GA 30043

PRINCIPAL DISPLAY PANEL - 228 mL Bottle Label

noble
roots®

Hand
Sanitizer
Infused with
Moisturizing
Aloe Vera

8 oz (228 mL)

PRINCIPAL DISPLAY PANEL - 228 mL Bottle Label
HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76577-010
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)  
Glycerin (UNII: PDC6A3C0OX)  
Hydroxyethyl Cellulose, Unspecified (UNII: T4V6TWG28D)  
Aloe Vera Leaf (UNII: ZY81Z83H0X)  
Citric Acid Monohydrate (UNII: 2968PHW8QP)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76577-010-08228 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/2020
2NDC:76577-010-803790 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart333A05/01/2020
Labeler - Noble Roots, LLC (106744122)
Establishment
NameAddressID/FEIBusiness Operations
Pharmco Laboratories, Inc.096270814MANUFACTURE(76577-010)

Revised: 6/2020
Document Id: 32691a63-78c6-4447-95cc-346198fc62d0
Set id: fd0621f3-6919-416d-99ec-5b726fcb0b9b
Version: 2
Effective Time: 20200612
 
Noble Roots, LLC