HAND SANITIZER- alcohol gel 
Casillas Tiscareno, María Guadalupe

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

DIRECTIONS

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.

INACTIVE INGREDIENTS

Inactive ingredients Water (Aqua), Glycerin, Carbomer, Triethanolamine

INDICATIONS AND USAGE

Use[s]

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

KEEP OUT OF REACH OF CHILDREN

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

PURPOSE

Purpose Antmicrobial

WARNINGS AND PRECAUTIONS

Store below 110°F (43°C)

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

in children less than 2 months of age
on open skin wounds

WARNINGS

Warnings

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

ACTIVE INGREDIENT

Active ingredient Ethyl Alcohol 70% v/v…

STOP USE AND ASK A DOCTOR

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

PACKAGE LABELS

LABEL 250 mlLABEL 500 mLLABEL 1000 mLLABEL 4000 mL FINAL

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79049-0030
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 0.2922 mL  in 1 mL
GLYCERIN (UNII: PDC6A3C0OX) 0.00375 mL  in 1 mL
TRIETHANOLAMINE CAPROYL GLUTAMATE (UNII: 0F2FO57253) 0.00185 mL  in 1 mL
CARBOMER 940 (UNII: 4Q93RCW27E) 0.0022 mL  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79049-0030-2250 mL in 1 BOTTLE; Type 0: Not a Combination Product06/16/2020
2NDC:79049-0030-3500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/16/2020
3NDC:79049-0030-41000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/16/2020
4NDC:79049-0030-54000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/16/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/16/2020
Labeler - Casillas Tiscareno, María Guadalupe (951579493)
Registrant - Casillas Tiscareno, María Guadalupe (951579493)
Establishment
NameAddressID/FEIBusiness Operations
Casillas Tiscareno, María Guadalupe951579493manufacture(79049-0030)

Revised: 6/2020
Document Id: a8406cab-a000-b9ec-e053-2995a90acb87
Set id: a8406cab-9fff-b9ec-e053-2995a90acb87
Version: 1
Effective Time: 20200616
 
Casillas Tiscareno, María Guadalupe