PURE CARE 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)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

to decrease bacteria on the skin that could cause disease. 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, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

purified water,propylene glycol, glycerin, carbomer, triethanolamine

Package Label - Principal Display Panel

60 mL NDC: 74765-010-01

150 mL NDC: 74765-010-02

236 mL NDC: 74765-010-03 236ml

PURE CARE HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74765-010
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)  
GLYCERIN (UNII: PDC6A3C0OX)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
CARBOMER 980 (UNII: 4Q93RCW27E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74765-010-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
2NDC:74765-010-02150 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
3NDC:74765-010-03236 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
4NDC:74765-010-04500 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(74765-010)

Revised: 5/2020
Document Id: a583d72d-40dd-4d5e-e053-2995a90abdd4
Set id: a4e30e68-7cea-b852-e053-2995a90a91c9
Version: 11
Effective Time: 20200513
 
Zhejiang Yiwu Limei Cosmetics Co., Ltd