SAN-X E3

Main information

  • Trade name:
  • SAN-X E3- ethanol liquid
  • Composition:
  • ALCOHOL 62 mL in 100 mL
  • Administration route:
  • TOPICAL
  • Prescription type:
  • OTC DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • SAN-X E3- ethanol liquid
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Purpose Hand Sanitizer 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

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • OTC monograph not final
  • Authorization number:
  • 69884-703-06
  • Last update:
  • 02-06-2019

Summary of Product characteristics: dosage, interactions, side effects

SAN-X E3- ethanol liquid

Amerisan, 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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SAN-X E3 Hand Sanitizer Foam

Drug Facts

Active Ingredient

Ethanol 62%

Purpose

Hand Sanitizer

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

For external use only

Flammable, keep away from fire or flame

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.

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

Directions

Receive a small amount of foam into palm of hand

Rub thoroughly over all surfaces of both hands

Rub hands together until dry

Other information

Store in a cool, dry place below 104°F

Inactive ingredients

DEA-C8-18 perfluoroalkylethylphosphate, glycereth-2 cocoate, denatonium benzoate, tert-butyl

alcohol, water

Questions?

Contact Amerisan, Mon-Fri

9am - 4pm EDT at 888-586-7990

Manufactured for:

Amerisan, LLC.

1833 Columbia Ave., Folcroft, PA 19032

SAN-X E3

Hand Sanitizer Foam

Engineered to meet the tough requirements of the food industry

Kills 99.999% of tested pathogens in 15 seconds

AMERISAN

WWW.AMERISAN.COM

WWW.AMERISANUSA.COM

Net Contents: 1250 mL (42.27 fl. oz.)

Fits Dispensers

Manual E713

Auto E710

SAN-X E3

ethanol liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 9 8 8 4-70 3

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ALCO HO L (UNII: 3K9 9 58 V9 0 M) (ALCOHOL - UNII:3K9 9 58 V9 0 M)

ALCOHOL

6 2 mL in 10 0 mL

Inactive Ingredients

Amerisan, LLC

Ingredient Name

Stre ng th

GLYCERETH-2 CO CO ATE (UNII: JWM0 0 VS7HC)

DENATO NIUM BENZO ATE (UNII: 4YK5Z54AT2)

TERT-BUTYL ALCO HO L (UNII: MD8 3SFE9 59 )

WATER (UNII: 0 59 QF0 KO0 R)

DIETHANO LAMINE BIS( C8 -C18 PERFLUO RO ALKYLETHYL) PHO SPHATE (UNII: 4J55VM50 9 S)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:6 9 8 8 4-70 3-

1250 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 2/19 /20 16

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333E

0 2/12/20 16

Labeler -

Amerisan, LLC (170260090)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Best Sanitizers

6 27278 224

ma nufa c ture (6 9 8 8 4-70 3)

Revised: 1/2019