ANTIBACTERIAL HAND SANITIZER- alcohol gel 
Hubei Flex Daily Chemicals 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.

----------

81131-001

Drug Fact

Active Ingredient(s)

Ethyl Alcohol 62%. 

Purpose

Antiseptic

Use

Hand sanitizer to help decrease bacterial on the skkin when water, soap and towel are not available

Recommended for repeated use

Warnings

For external use only.

Flammable. Keep away from fire or flame

Do not apply around eyes. Do not use in ears and mouth.

When using this product, avoid contact with eyes.  In case of contact, flush eyes with water

Stop use and ask a doctor if redness or irritation develop and persist for more than 72 hours.

Keep out of reach of children. Children must be spervised when use this product.

Directions

Squirt as needed into your palms and thoroughly spread on both hands, rub into skin until dry.

Other information

Store st 20C (68-77F)

May discolor some fabrics

Inactive ingredients

Water, glycerin, triethanolamine, carbomer, Vitamin E, aloe barbadensis leaf extract

image description

ANTIBACTERIAL HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81131-001
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
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
TROLAMINE (UNII: 9O3K93S3TK)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81131-001-0115 mL in 1 BOTTLE; Type 0: Not a Combination Product08/17/2021
2NDC:81131-001-0230 mL in 1 BOTTLE; Type 0: Not a Combination Product08/17/2021
3NDC:81131-001-0335 mL in 1 BOTTLE; Type 0: Not a Combination Product08/17/2021
4NDC:81131-001-0460 mL in 1 BOTTLE; Type 0: Not a Combination Product08/17/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/17/2021
Labeler - Hubei Flex Daily Chemicals CO., LTD (554533593)
Establishment
NameAddressID/FEIBusiness Operations
Hubei Flex Daily Chemicals CO., LTD554533593manufacture(81131-001)

Revised: 8/2022
Document Id: e5eb3c90-55a4-5490-e053-2995a90a1dbc
Set id: 47349a42-08f4-48cd-acc0-0fd541d447be
Version: 2
Effective Time: 20220810
 
Hubei Flex Daily Chemicals CO., LTD