GRAND INNOVATIONS HAND SANITIZER- 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)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help decrease bacteria on skin. when water, soap& towel are not available. recommended for repeated use.

Warnings

For external use only: hands. Flammable. Keep away from fire or flame

Do not use

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 supervised in use of this product.


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 supervised in use of this product.

Directions

wet hands thoroughly with product and allow to dry without wiping for children under 6, use only under adult supervision,
not recommended for infants

Other information


store between 59-86F (15~30C) ,may discolor some fabrics, harmful to wood finishes and plastics

Inactive ingredients

water, propylene glycol,glycerin, carbomer.triethanolamine

Package Label - Principal Display Panel

50 mL NDC: 74765-011-01 50ml label

150 mL NDC: 74765-011-02

236 mL NDC: 74765-011-03

500 mL NDC: 74765-011-04

GRAND INNOVATIONS HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74765-011
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CARBOMER 980 (UNII: 4Q93RCW27E)  
GLYCERIN (UNII: PDC6A3C0OX)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74765-011-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
2NDC:74765-011-02150 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
3NDC:74765-011-03236 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
4NDC:74765-011-04500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - Zhejiang Yiwu Limei Cosmetics Co., Ltd (679892245)
Establishment
NameAddressID/FEIBusiness Operations
Zhejiang Yiwu Limei Cosmetics Co., Ltd679892245manufacture(74765-011)

Revised: 5/2020
Document Id: a4e46040-2388-4456-e053-2a95a90a6a7a
Set id: a4e4617e-9ed2-1861-e053-2995a90a3971
Version: 11
Effective Time: 20200505
 
Zhejiang Yiwu Limei Cosmetics Co., Ltd