4 YOUR SAFETY HAND SANITIZER- alcohol gel 
Montenegro Castro, Carlos

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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4 your safety Hand sanitizer

Drug Facts

Active ingredient[s]

Ethyl Alcohol 70% v/v

Purpose

Antimicrobial

Use[s]

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

Warnings

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

Do not use

  • in 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 thoroughly with water.

Stop use and ask a doctor

if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

Glycerin, Carbomer, Purified Water

Package Labeling:60ml

Bottle

Package Labeling:250ml

Bottle2

Package Labeling:500ml

Bottle3

Package Labeling:1000ml

Bottle4

4 YOUR SAFETY HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79252-001
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
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79252-001-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product07/30/2020
2NDC:79252-001-02250 mL in 1 BOTTLE; Type 0: Not a Combination Product07/30/2020
3NDC:79252-001-03500 mL in 1 BOTTLE; Type 0: Not a Combination Product07/30/2020
4NDC:79252-001-041000 mL in 1 BOTTLE; Type 0: Not a Combination Product07/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E07/30/2020
Labeler - Montenegro Castro, Carlos (951577488)

Revised: 8/2020
Document Id: ac8a2750-e70f-4d0d-e053-2995a90a3115
Set id: ac8a5507-b08c-065b-e053-2a95a90a339d
Version: 1
Effective Time: 20200810
 
Montenegro Castro, Carlos