NOT HAVE- hand sanitiser gel 
Jiangxi Iris Chemical Co.,Ltd

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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​HAND SANITISER

Active ingredient[s]

Alcohol 75%v/v

Purpose

Antiseptic

Use[s]

Hand sanitizer to help reduce bacteria that potentially can cause disease.

For use when soap and water are not available.

Warnings

For external use only.Flammable.Keep away from heat or flame.

Do not use

in children less than 2 months of age

on open skin wounds

When using this product

keep out of eyes,ears, and mouth.In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs.These may be signs of a serious condition.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Place enough product on hands to cover all surfaces.Rub hands together until dry.

Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

Store between 15-30C(59-86F).

Avoid freezing and excessive heat above 40C(104F).

Inactive ingredients

Water(Aqua) ,Carbomer,Triethanolamine,Tocopheryl Acetate.

Package Label - Principal Display Panel

60 ml label 100 ml label 250 ml label 500 ml label 1000 ml label

NOT HAVE 
hand sanitiser gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74440-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74440-003-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product05/07/2020
2NDC:74440-003-02100 mL in 1 BOTTLE; Type 0: Not a Combination Product05/07/2020
3NDC:74440-003-03250 mL in 1 BOTTLE; Type 0: Not a Combination Product05/07/2020
4NDC:74440-003-04500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/07/2020
5NDC:74440-003-051000 mL in 1 BOTTLE; Type 0: Not a Combination Product05/07/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/07/2020
Labeler - Jiangxi Iris Chemical Co.,Ltd (544366795)
Registrant - Jiangxi Iris Chemical Co.,Ltd (544366795)
Establishment
NameAddressID/FEIBusiness Operations
Jiangxi Iris Chemical Co.,Ltd544366795manufacture(74440-003)

Revised: 5/2020
Document Id: a5061bcf-6acb-1544-e053-2995a90acb65
Set id: a507d26b-397f-c4d1-e053-2a95a90a5512
Version: 1
Effective Time: 20200506
 
Jiangxi Iris Chemical Co.,Ltd