SANTOTIZER- hand santizer solution liquid 
Santolubes 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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Alcohol 80% v/v

1.3oz3600 ml label

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.
Supervise children under 6 years of age when using this product to avoid swallowing.

Warnings

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

Inactive ingredients glycerin, hydrogen peroxide, purified water

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

Purpose

Antiseptic

3,600ml NDC 73976-1330-1

18,000ml NDC 73976-1330-2

200,000ml NDC 73976-1330-3

1,022,000ml NDC 73976-1330-4 3600ml 18000ml200000ml1022000ml

SANTOTIZER 
hand santizer solution liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73976-1330
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 L  in 100 L
Inactive Ingredients
Ingredient NameStrength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 L  in 100 L
WATER (UNII: 059QF0KO0R) 18.4 L  in 100 L
GLYCERIN (UNII: PDC6A3C0OX) 1.45 L  in 100 L
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73976-1330-3200 L in 1 DRUM; Type 0: Not a Combination Product03/30/2020
2NDC:73976-1330-13.6 L in 1 PAIL; Type 0: Not a Combination Product03/30/2020
3NDC:73976-1330-218 L in 1 PAIL; Type 0: Not a Combination Product03/30/2020
4NDC:73976-1330-41022 L in 1 TANK; Type 0: Not a Combination Product03/30/2020
5NDC:73976-1330-60.0384456 L in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/16/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - Santolubes LLC (144734980)
Registrant - Santolubes LLC (144734980)
Establishment
NameAddressID/FEIBusiness Operations
Santolubes LLC144734980manufacture(73976-1330)

Revised: 4/2021
Document Id: c11f0d97-8e5b-1dfe-e053-2a95a90a8c3e
Set id: a18cef50-abdf-a416-e053-2a95a90a83de
Version: 4
Effective Time: 20210429
 
Santolubes LLC