HAND SANITIZER- alcohol gel 
Solve Together, 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

Antiseptic

Use(s)

For sanitizing to help reduce bacteria on the skin that potentially can cause disease.

Warnings

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

Do not use

  • With 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.

Keep out of the reach of children unless under adult supervision. If swallowed, get medical help or contact a poison control center right away.

Directions

Other Information

Store in between 5°-30°C (41°-86°F)

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

Inactive Ingredients

Water (Aqua), Carbomer, Glycerin, Triethanolamine, Tocopheryl Acetate (Vitamin E)

DISTRIBUTED BY
TRADEMARK BRAND LLC
1 Bridge Plaza N Ste 475
Fort Lee, NJ 07024

PRINCIPAL DISPLAY PANEL - 59 ML Bottle Label

Safe Choice

TRADEMARK
BRAND

Zestfully Efficacious
HAND
SANITIZER

KILLS 99.9% OF GERMS*

Antibacterial

70% ALCOHOL

2 FL OZ (59 ML)

PRINCIPAL DISPLAY PANEL - 59 ML Bottle Label
HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79882-001
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)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
GLYCERIN (UNII: PDC6A3C0OX)  
TROLAMINE (UNII: 9O3K93S3TK)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79882-001-0159 mL in 1 BOTTLE; Type 0: Not a Combination Product11/19/2020
2NDC:79882-001-02250 mL in 1 BOTTLE; Type 0: Not a Combination Product11/19/2020
3NDC:79882-001-031000 mL in 1 BOTTLE; Type 0: Not a Combination Product11/19/2020
4NDC:79882-001-043700 mL in 1 BOTTLE; Type 0: Not a Combination Product11/19/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart333A11/19/2020
Labeler - Solve Together, LLC (117539166)
Establishment
NameAddressID/FEIBusiness Operations
Organikisimo, S.A. de C:V951579669MANUFACTURE(79882-001)

Revised: 12/2020
Document Id: 58a04c36-6426-491f-a4ec-d1c450db6c5d
Set id: 89d34bea-255f-4af9-b965-60402bb4301c
Version: 1
Effective Time: 20201203
 
Solve Together, LLC