ALCOHOL  - alcohol gel 
Nantong Health & Beyond Hygienic Products 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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Drug Facts

Inactive Ingredients

carbomer 940, glycerin,

propylene glycol, red 33,

tocopheryl acetate,

triethonamoline, water

Active Ingredient

Ethyl Alcohol, 65 % v/v

Purpose    Antimicrobial

Warnings

For external use only

Keep out of reach of children. If swallowed,

get medical help or contact a Poison

Control Center right away.

Directions. Put a dime sized

drop onto hands and rub

briskly until dry.

Uses.  hand sanitizer to help

reduce bacteria on skin

Do not use in or near the eyes.

In case of contact, rinse eyes

thoroughly with water.

Flammable. Keep away from

fire or flame

Stop use and ask a doctor

if irritation, excessive redness

or rash develops

Other information

Store below 110 F ( 43 C)

copy of label
ALCOHOL  
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43473-805
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43473-805-0129 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/01/2014
Labeler - Nantong Health & Beyond Hygienic Products Inc. (421280161)
Establishment
NameAddressID/FEIBusiness Operations
Nantong Health & Beyond Hygienic Products Inc.421280161manufacture(43473-805)

Revised: 9/2014
Document Id: 201e506e-c0e9-4431-9c52-9a6d67a59a05
Set id: b833cb94-cc8f-42af-ba79-01c81b53be23
Version: 1
Effective Time: 20140901
 
Nantong Health & Beyond Hygienic Products Inc.