HAND SANITIZER- ethanol liquid 
Saraya Healthcare

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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SARAYA HAND SANITIZER FOAM

Drug Facts

Active Ingredient

Ethanol 62%

Purpose

Hand Sanitizer

Uses

Warnings

When using this product

Keep out of reach of children

In case of accidental ingestion, seek medical attention or contact a poison control center immediately

Directions

Other information

Inactive ingredients

Water, DEA-C8-18 perfluoroalkylethyl phosphate, glycereth-2 cocoate, denatonium benzoate, tert-butyl alcohol

Questions?

Contact Saraya Healthcare USA Mon - Fri

9am - 4pm PST at 866.822.1801

Distributed by:

Saraya Healthcare USA

P.O. Box 1360

Penn Valley, CA 95946

866.822.1801

sarayahealthcareusa.com

SARAYA Healthcare USA

- Kills 99.999% of 26 tested pathogens in 15 seconds

- Formulated with emollients to help keep hands soft

- 62% Ethanol formula

Hand Sanitizer Foam

Net Contents: 1250mL (42 fl oz)

Saraya Alc Hand Sanitizer Foam

HAND SANITIZER 
ethanol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69674-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
DIETHANOLAMINE BIS(C8-C18 PERFLUOROALKYLETHYL)PHOSPHATE (UNII: 4J55VM509S)  
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
WATER (UNII: 059QF0KO0R)  
GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)  
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69674-100-01500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/14/2016
2NDC:69674-100-041250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/14/2016
3NDC:69674-100-0745 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/14/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E04/14/2016
Labeler - Saraya Healthcare (079729980)
Establishment
NameAddressID/FEIBusiness Operations
Best Sanitizers627278224manufacture(69674-100)

Revised: 1/2019
Document Id: 7e8358db-8957-169c-e053-2991aa0a545d
Set id: 30c68860-c7ff-5dbb-e054-00144ff8d46c
Version: 2
Effective Time: 20190102
 
Saraya Healthcare