AG LINEA HAND SANITIZER- ethyl alcohol gel 
Natural Dyes Inc

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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AG LINEA HAND SANITIZER

Drug Facts

Active ingredient

Ethyl Alcohol 70%

Purpose

Antiseptic

Uses

Warnings

For external use only: hands.

Flammable. Keep away from fire or flame.

When using this product • Keep out of eyes, ears, or mouth. • In case of eye contact, flush eyes thoroughly with water. • Avoid contact with broken skin. • Do not inhale or ingest.

Stop use and ask a doctor if • redness or irritation develop

• condition persists for more than 72 hours

Keep out of reach of children.

• Children should be supervised by an adult when using this product. • If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Wet hand thoroughly with product and allow to dry without wiping. • No rinsing required. • For children under 6, use only under adult supervision. • Not recommended for infants.

Other information

• Store below 105˚F(40˚C). • May discolor certain fabrics. • Harmful to wood finishes & plastics

Inactive ingredients:

Water(Aqua), Triethanolamine, Carbomer, Aloe Barbadensis(Aloe Vera) Gel, Fragrance, Glycerin, Propylene Glycol, Tocopheryl Acetate(Vitamin E).

Distributed by:

Natural Dyes Inc.

New York, NY 10018

Made in China

UPC CODE

Kills 99.9% of Germs

ADVANCED MOISTURIZING FORMULA WITH ALOE AND VITAMIN E

HOW TO USE HAND SANITIZER

Dispense a coin sized drop of sanitizer on your palm.

Spread the sanitizer and rub palms together.

Rub sanitizer on palms, between fingers, finger tips, and back of hands.

Rub hands together for 20 seconds until sanitizer dries.

Packaging

IMAGE

IMAGE

image description

AG LINEA HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77781-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Alcohol (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) Alcohol70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77781-001-0460 mL in 1 BOTTLE; Type 0: Not a Combination Product05/30/2020
2NDC:77781-001-01237 mL in 1 BOTTLE; Type 0: Not a Combination Product05/30/2020
3NDC:77781-001-03500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/30/2020
Labeler - Natural Dyes Inc (078772235)
Establishment
NameAddressID/FEIBusiness Operations
Taizhou Huangyan Liweir Cosmetic Technology LTD560781517manufacture(77781-001)
Establishment
NameAddressID/FEIBusiness Operations
Sanrace Biotechnology Co., Ltd.543000938manufacture(77781-001)

Revised: 8/2020
Document Id: 4e78898a-e1e4-45fe-8d14-a3c630b6f315
Set id: 82ff206d-2287-482c-89b1-8d09aa5a6a58
Version: 2
Effective Time: 20200811
 
Natural Dyes Inc