HAND SANITIZER- alcohol liquid 
MEDICORE MED 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[s]

Denatured ALCOHOL 80% V/V

Purpose

Antiseptic

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 eyes 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 igradients

glicerin, hidrogen peroxide, purified woter USP

Package Labeling:950ml

Bottle

Package Labeling:236ml

LabelLabel2

Package Labeling:473ml

BoxBox2

HAND SANITIZER 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78112-080
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.8 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78112-080-01950 mL in 1 BOTTLE; Type 0: Not a Combination Product07/26/2020
2NDC:78112-080-03236 mL in 1 BOTTLE; Type 0: Not a Combination Product11/23/2021
3NDC:78112-080-073800 mL in 1 BOTTLE; Type 0: Not a Combination Product11/23/2021
4NDC:78112-080-02473 mL in 1 BOTTLE; Type 0: Not a Combination Product11/30/2021
5NDC:78112-080-0659 mL in 1 BOTTLE; Type 0: Not a Combination Product11/30/2021
6NDC:78112-080-08118 mL in 1 BOTTLE; Type 0: Not a Combination Product11/30/2021
7NDC:78112-080-0930 mL in 1 BOTTLE; Type 0: Not a Combination Product11/30/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E07/26/2020
Labeler - MEDICORE MED LLC (113045254)

Revised: 11/2021
Document Id: d2090681-4987-93a4-e053-2a95a90a1ecd
Set id: 2db72a20-48b8-41a1-9882-a296d18efa56
Version: 17
Effective Time: 20211130
 
MEDICORE MED LLC