IRIS HAND SANITIZING WIPES- alcohol cloth 
Amerifoods Trading Company

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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Active Ingredient (in each wipe)

Ethyl Alcohol .....62%

Purpose

Antimicrobial

Indications and Usages

Warnings

For external use only

Flammable: keep away from fire or flame

When using this product do not use in or near eyes. If contact occurs, flush thoroughly with water.

Stop use and contact a doctor if irritation or redness persists for more than 72 hours.

Keep out of reach of children unless inder adult supervision. if swallowed, get medical help or contact a Poison Control Center right away.

Keep out of reach of children

Keep out of reach of children unless inder adult supervision. if swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive Ingredients

Aloe barbadensis leaf juice, tocopheryl acetate, water

Label

Kills 99.99% of germs

Iris Hand Sanitizing Wipes

Moisturizes with aloe vera & vitamin E

240 Pre-treated textured sheets

240 wipes 5.5 in x 6.75 in (13.97 cmx 17.14 cm)

Label

IRIS HAND SANITIZING WIPES 
alcohol cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61504-140
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 g  in 100 g
ALOE VERA LEAF (UNII: ZY81Z83H0X) (ALOE VERA LEAF - UNII:ZY81Z83H0X) ALOE VERA LEAF.01 g  in 100 g
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) ALPHA-TOCOPHEROL ACETATE.01 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 37.98 g  in 100 g
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61504-140-30488 g in 1 CANISTER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E01/31/2016
Labeler - Amerifoods Trading Company (626388680)
Establishment
NameAddressID/FEIBusiness Operations
Diamond Wipes International161104729manufacture(61504-140)

Revised: 1/2016
Document Id: 9cce1579-f1b9-47d8-8068-56646a3197ea
Set id: 3f7bd7af-903b-46c0-9c28-0cc06e460a2c
Version: 1
Effective Time: 20160106
 
Amerifoods Trading Company