HAND SANITIZER- hand sanitizer gel 
Sanlingyi(Guangdong)Medical Biotechnology 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 Sanitizer GEL

Active Ingredient(s)

Alcohol 75%v/v

Purpose

Antiseptic


Use

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 SECTION

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.

OTC-STOP USE SECTION

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

Alcohol、Glycerin、Trolamine、Polyacrylic acid

Package Label - Principal Display Panel

3 ml -5000L label

HAND SANITIZER 
hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78351-001
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
GLYCERIN (UNII: PDC6A3C0OX)  
TROLAMINE (UNII: 9O3K93S3TK)  
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78351-001-013 mL in 1 BOTTLE; Type 0: Not a Combination Product05/18/2020
2NDC:78351-001-0230 mL in 1 BOTTLE; Type 0: Not a Combination Product05/18/2020
3NDC:78351-001-0350 mL in 1 BOTTLE; Type 0: Not a Combination Product05/18/2020
4NDC:78351-001-0460 mL in 1 BOTTLE; Type 0: Not a Combination Product05/18/2020
5NDC:78351-001-05100 mL in 1 BOTTLE; Type 0: Not a Combination Product05/18/2020
6NDC:78351-001-06250 mL in 1 BOTTLE; Type 0: Not a Combination Product05/18/2020
7NDC:78351-001-07275 mL in 1 BOTTLE; Type 0: Not a Combination Product05/18/2020
8NDC:78351-001-08300 mL in 1 BOTTLE; Type 0: Not a Combination Product05/18/2020
9NDC:78351-001-09375 mL in 1 BOTTLE; Type 0: Not a Combination Product05/18/2020
10NDC:78351-001-10500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/18/2020
11NDC:78351-001-11580 mL in 1 BOTTLE; Type 0: Not a Combination Product05/18/2020
12NDC:78351-001-121000 mL in 1 BOTTLE; Type 0: Not a Combination Product05/18/2020
13NDC:78351-001-132000 mL in 1 BOTTLE; Type 0: Not a Combination Product05/18/2020
14NDC:78351-001-145000000 mL in 1 BOTTLE; Type 0: Not a Combination Product05/18/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/18/2020
Labeler - Sanlingyi(Guangdong)Medical Biotechnology Co.,Ltd. (554532954)
Registrant - Sanlingyi(Guangdong)Medical Biotechnology Co.,Ltd. (554532954)
Establishment
NameAddressID/FEIBusiness Operations
Sanlingyi(Guangdong)Medical Biotechnology Co.,Ltd.554532954manufacture(78351-001)

Revised: 5/2020
Document Id: a64e4f9b-2d07-e113-e053-2995a90aa7d5
Set id: a64e4f9b-2d06-e113-e053-2995a90aa7d5
Version: 1
Effective Time: 20200517
 
Sanlingyi(Guangdong)Medical Biotechnology Co.,Ltd.