HAND SANITIZER- ethanol liquid

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Saraya Healthcare, Best Sanitizers. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENT

Active Ingredient

Ethanol 62%

PURPOSE

Purpose

Hand Sanitizer

INDICATIONS & USAGE

Uses

• Sanitizes hands to help reduce bacteria that potentially can cause diseases
• Helps to prevent cross-contamination
• Helps to prevent drying of the skin
• Recommended for repeated use

WARNINGS

Warnings

• For external use only
• Flammable, keep away from fire or flame

WHEN USING

When using this product

• Do not use in or near eyes
• Use in a well-ventilated area
• Discontinue use if irritation and redness develop

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

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

DOSAGE & ADMINISTRATION

Directions

• Receive a small amount of foam into palm of hand
• Rub thoroughly over all surfaces of both hands, especially fingernails and cuticles
• Rub hands together until dry

STORAGE AND HANDLING

Other information

• Store in a cool, dry place below 104°F

INACTIVE INGREDIENT

Inactive ingredients

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

QUESTIONS

Questions?

Contact Saraya Healthcare USA Mon - Fri

9am - 4pm PST at 866.822.1801

SPL UNCLASSIFIED SECTION

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)

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
ethanol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69674-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69674-100-01	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/14/2016
2	NDC: 69674-100-04	1250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/14/2016
3	NDC: 69674-100-07	45 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/14/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	04/14/2016

Labeler - Saraya Healthcare (079729980)

Establishment
Name	Address	ID/FEI	Business Operations
Best Sanitizers		627278224	manufacture(69674-100)