PROSERA HAND SANITIZER- ethyl alcohol spray 
D-Time Limited Liability Company

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.

----------

Active Ingredient

Ethyl alcohol 80%

Purpose

Antiseptic skin cleanser

Uses

 For personal hand hygiene to help prevent the spread of bacteria

Warnings

For external use only

When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop use and consult a healthcare professional if irritation develops.

Flammable. Keep away from open flame and sources of heat

Keep out of reach of children.

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

Directions

Inactive ingredients

Aqua, Glycerin, Vitamin E, Sage Oil, Hydrogen peroxide, Sodium pyruvate

Other Information

Store at 68° to 70° F (20° to 25° C). May discolor certain fabrics or surfaces.

Label

Label

PROSERA HAND SANITIZER 
ethyl alcohol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75306-008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
SAGE OIL (UNII: U27K0H1H2O)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
SODIUM PYRUVATE (UNII: POD38AIF08)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75306-008-0130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/01/2020
2NDC:75306-008-0250 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/01/2020
3NDC:75306-008-0360 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/01/2020
4NDC:75306-008-04100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/01/2020
5NDC:75306-008-05120 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/01/2020
6NDC:75306-008-06150 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/01/2020
7NDC:75306-008-07160 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/01/2020
8NDC:75306-008-08200 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/01/2020
9NDC:75306-008-09250 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/01/2020
10NDC:75306-008-10500 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/01/2020
11NDC:75306-008-111000 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/01/2020
12NDC:75306-008-123785 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/01/2020
13NDC:75306-008-1318927 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/01/2020
14NDC:75306-008-145000 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/01/2020
15NDC:75306-008-1510000 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/01/2020
16NDC:75306-008-1615000 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/01/2020
17NDC:75306-008-1720000 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/01/2020
Labeler - D-Time Limited Liability Company (081728006)
Establishment
NameAddressID/FEIBusiness Operations
D-Time Limited Liability Company081728006manufacture(75306-008)

Revised: 11/2021
Document Id: cfd132e3-0bdc-de04-e053-2a95a90adc45
Set id: af0a9f81-04e6-4906-bf34-c54fad3914b0
Version: 2
Effective Time: 20211102
 
D-Time Limited Liability Company