HAND SANITIZER- alcohol gel 
Living Essentials Corp.

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

Drug Facts

Active ingredient

Alcohol 70% v/v

Purpose

Antiseptic

Uses

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, and mouth

     In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor

if irritation or redness develops.

Keep out of reach of children.

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

Directions

Other information

Inactive ingredients

Water, Glycerin, Aloe Barbadensis Extract, Aminomethyl Propanol, Propylene Glycol, Carbomer, Fragrance, Tocopherol.

Package Labeling : 236ml

Label1

Package Labeling : 1000ml

Label2

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78628-008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78628-008-08236 mL in 1 BOTTLE; Type 0: Not a Combination Product05/28/2020
2NDC:78628-008-331000 mL in 1 BOTTLE; Type 0: Not a Combination Product05/28/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E05/28/2020
Labeler - Living Essentials Corp. (117027538)
Establishment
NameAddressID/FEIBusiness Operations
Yuyao Huanyan Daily Chemical Products Co., Ltd554527491manufacture(78628-008)

Revised: 6/2020
Document Id: a78faa3a-4673-81b6-e053-2995a90a3233
Set id: 83266ab3-ed48-499a-9bc0-e17a844c048a
Version: 1
Effective Time: 20200608
 
Living Essentials Corp.