EZ-SAN ANTISEPTIC HAND SANITIZER: Package Insert and Label Information

EZ-SAN ANTISEPTIC HAND SANITIZER- alcohol gel
AMERASIAN FRAGRANCE RESEARCH LIMITED-(BRANCH)

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.

Drug Facts

Active ingredient

Ethyl alcohol 70%

Purpose

Antiseptic

Uses • hand sanitizer to decrease bacteria on the skin

• recommended for repeated use

• for use when soap and water are not available

Warnings

Flammable, Keep away from fire/flame

For external use only

Do not use in children less than 2 months of age • on open skin wounds

When using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water

Stop use and ask a doctor if • irritation and redness develop • condition persists for more than 72 hours

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Directions • wet hands thoroughly with product and allow to dry without wiping • supervise children under 6 years of age when using this product to avoid swallowing

Other informationStore between 15-30ºC (59-86ºF) • avoid freezing and excessive heat above 40ºC (104ºF)

Inactive ingredients aminomethyl propanol, carbomer, glycerin, water

Questions? +1-901-373-7818

You may also report serious side effects to this phone number. Mon-Fri 9:00 AM — 5:00 PM

© 2020 Vectair System Ltd.

LAB-1210-001

VECTAIR SYSTEMS

Distributed by: Vectair Systems, Inc.

Distribution Center, Covington Way, 2095 Spicer Cove, Memphis, TN 38134

COUNTRY OF ORIGIN: THAILAND www.vectairsystems.com

Packaging

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EZ-SAN ANTISEPTIC HAND SANITIZER
ethyl alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:78008-111
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 0.70 mL in 1 mL
Inactive Ingredients
Ingredient Name Strength
AMINOMETHYLPROPANOL
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
GLYCERIN
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:78008-111-02 59 mL in 1 BOTTLE None
2 NDC:78008-111-24 710 mL in 1 BOTTLE None
3 NDC:78008-111-00 100 PACKET in 1 BOX contains a PACKET (78008-111-01)
3 NDC:78008-111-01 1.5 mL in 1 PACKET This package is contained within the BOX (78008-111-00)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 05/25/2020
Labeler — AMERASIAN FRAGRANCE RESEARCH LIMITED-(BRANCH) (661750002)
Establishment
Name Address ID/FEI Operations
AMERASIAN FRAGRANCE RESEARCH LIMITED-(BRANCH) 661750002 manufacture (78008-111)

Revised: 07/2020 AMERASIAN FRAGRANCE RESEARCH LIMITED-(BRANCH)

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