HAND SANITIZER- ethyl alcohol gel 
Yuyao Jessie 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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51414-912 HAND SANITIZER Ethyl Alcohol 62%

Active Ingredient(s)

Ethyl Alcohol 62%

Purpose

Antiseptic

Use

for hand sanitizing

Warnings

For external use only.
Flammable, Keep away from heat or flame,
When using this product keep out of eyes, flush thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest.

Stop use and ask a doctor if irritation develops.

Keep out of reach of children. except under adult supervision.

If swallowed, get medical help or call a poison control center right away.

Directions

Wet hands thoroughly with product and allow to dry without wiping.

For children under 6 age use only under adult supervision.

Not recommended for infants.

Inactive ingredients

Carborner,Fragrance,Glycerin,Propylene Glycol,TocopherylAcetate,Triethanolamine,Water.

Package Label - Principal Display Panel

1

HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51414-912
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51414-912-01300 mL in 1 BOTTLE; Type 0: Not a Combination Product10/10/2020
2NDC:51414-912-0210 mL in 1 BOTTLE; Type 0: Not a Combination Product10/10/2020
3NDC:51414-912-0315 mL in 1 BOTTLE; Type 0: Not a Combination Product10/10/2020
4NDC:51414-912-0420 mL in 1 BOTTLE; Type 0: Not a Combination Product10/10/2020
5NDC:51414-912-05480 mL in 1 BOTTLE; Type 0: Not a Combination Product10/10/2020
6NDC:51414-912-0630 mL in 1 BOTTLE; Type 0: Not a Combination Product10/10/2020
7NDC:51414-912-073785 mL in 1 BOTTLE; Type 0: Not a Combination Product10/10/2020
8NDC:51414-912-0850 mL in 1 BOTTLE; Type 0: Not a Combination Product10/10/2020
9NDC:51414-912-0960 mL in 1 BOTTLE; Type 0: Not a Combination Product10/10/2020
10NDC:51414-912-10120 mL in 1 BOTTLE; Type 0: Not a Combination Product10/10/2020
11NDC:51414-912-1190 mL in 1 BOTTLE; Type 0: Not a Combination Product10/10/2020
12NDC:51414-912-128 mL in 1 BOTTLE; Type 0: Not a Combination Product10/10/2020
13NDC:51414-912-130.9 mL in 1 BOTTLE; Type 0: Not a Combination Product10/10/2020
14NDC:51414-912-145 mL in 1 BOTTLE; Type 0: Not a Combination Product10/10/2020
15NDC:51414-912-1525 mL in 1 BOTTLE; Type 0: Not a Combination Product10/10/2020
16NDC:51414-912-16240 mL in 1 BOTTLE; Type 0: Not a Combination Product10/10/2020
17NDC:51414-912-1735 mL in 1 BOTTLE; Type 0: Not a Combination Product10/10/2020
18NDC:51414-912-1875 mL in 1 BOTTLE; Type 0: Not a Combination Product10/10/2020
19NDC:51414-912-1918 mL in 1 BOTTLE; Type 0: Not a Combination Product10/10/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/10/2020
Labeler - Yuyao Jessie Commodity Co., Ltd. (529892305)
Registrant - Yuyao Jessie Commodity Co., Ltd. (529892305)
Establishment
NameAddressID/FEIBusiness Operations
Yuyao Jessie Commodity Co., Ltd.529892305manufacture(51414-912)

Revised: 3/2022
Document Id: da8ab831-a0ba-526b-e053-2a95a90a18ce
Set id: b146adac-104f-a542-e053-2a95a90ac3df
Version: 3
Effective Time: 20220318
 
Yuyao Jessie Commodity Co., Ltd.