DISPOSABLE HAND SANITIZING- alcohol gel 
Ningbo Qiyu Commodity 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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Disposable Hand Sanitizing Gel

Drug Facts

Active ingredient

Alcohol, 75% v/v

Purpose

Antiseptic

Use

Decreases bacteria on hands

Warnings

For external use only
Flammable, keep away from fire or flame

When using this product

keep out of eyes.

Discontinue use 

if irritation and redness develops. If condition persists for more than 72 hours consult a doctor.

Keep out of reach of children

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

Directions

Place a 'palmful' of product in one hand. Spread on both hands and rub the skin until dry.

Other Information

To report a serious adverse reaction please write to Added Extras, 16# Yonghe Road, Beilun District, Ningbo City, Zhejiang Province, China

Inactive ingredients

Aqua, Glycerin, Carbomer, Triethanolamine, Fragrance.

Package Labeling: 30ml

Label

Package Labeling: 100ml

Label2

Package Labeling: 250ml

Label3

Package Labeling: 500ml

Label4

Package Labeling: 1000ml

Label5

DISPOSABLE HAND SANITIZING 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76562-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.75 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76562-004-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
2NDC:76562-004-02100 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
3NDC:76562-004-03250 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
4NDC:76562-004-04500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
5NDC:76562-004-051000 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E05/01/2020
Labeler - Ningbo Qiyu Commodity Co., Ltd. (554518486)
Establishment
NameAddressID/FEIBusiness Operations
Ningbo Qiyu Commodity Co., Ltd.554518486manufacture(76562-004)

Revised: 6/2020
Document Id: a7328b29-b4a2-4178-e053-2995a90a043a
Set id: bd983bd2-4069-498b-a171-1000f6d545a4
Version: 1
Effective Time: 20200603
 
Ningbo Qiyu Commodity Co., Ltd.