LUOYS HAND SANITIER- alcohol gel 
ZheJiang Yiwu Limei Cosmetics 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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Active Ingredient(s)

Isopropyl Alcohol 75% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

For hand sanitizing to help decrease bacteria on the skin

Recommended for repeated use

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, flush eyes with water.

Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours

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, propylene glycol, glycerin, carbomer, triethanolamine

Package Label - Principal Display Panel

image description

LUOYS HAND SANITIER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74765-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
CARBOMER 934 (UNII: Z135WT9208)  
TRIETHANOLAMINE SULFATE (UNII: MV1V89M17O)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74765-001-0129 mL in 1 BOTTLE; Type 0: Not a Combination Product04/08/2020
2NDC:74765-001-0250 mL in 1 BOTTLE; Type 0: Not a Combination Product04/16/2020
3NDC:74765-001-0360 mL in 1 BOTTLE; Type 0: Not a Combination Product04/16/2020
4NDC:74765-001-04100 mL in 1 BOTTLE; Type 0: Not a Combination Product04/16/2020
5NDC:74765-001-05300 mL in 1 BOTTLE; Type 0: Not a Combination Product04/16/2020
6NDC:74765-001-06500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/16/2020
7NDC:74765-001-071000 mL in 1 BOTTLE; Type 0: Not a Combination Product04/16/2020
8NDC:74765-001-082000 mL in 1 BOTTLE; Type 0: Not a Combination Product04/16/2020
9NDC:74765-001-093000 mL in 1 BOTTLE; Type 0: Not a Combination Product04/16/2020
10NDC:74765-001-105000 mL in 1 BOTTLE; Type 0: Not a Combination Product04/16/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/08/2020
Labeler - ZheJiang Yiwu Limei Cosmetics Co., Ltd (679892245)
Establishment
NameAddressID/FEIBusiness Operations
ZheJiang Yiwu Limei Cosmetics Co., Ltd679892245manufacture(74765-001)

Revised: 4/2020
Document Id: a36f4fc3-9c22-c197-e053-2995a90a7285
Set id: bf54e3f6-e4b1-4613-9598-667c41fd47a6
Version: 2
Effective Time: 20200416
 
ZheJiang Yiwu Limei Cosmetics Co., Ltd