HAND SANITIZER- hand sanitizer gel 
Yiwu Pafa Trading Firm (General Partnership)

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 62% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

take about 2ml of this product and apply it directly to the skinof hand 1 mindy, no need to wash. Continuous multiple usepossible Slightly sticky and can be washed with water.

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 helper 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.

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

Directions

Other information

Inactive ingredients

glycerin, water, Carbomer, Triethanolamine

Package Label - Principal Display Panel

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HAND SANITIZER 
hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75759-001
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)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75759-001-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
2NDC:75759-001-02100 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
3NDC:75759-001-03200 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
4NDC:75759-001-04250 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
5NDC:75759-001-05500 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 - Yiwu Pafa Trading Firm (General Partnership) (551964379)
Establishment
NameAddressID/FEIBusiness Operations
Yiwu Pafa Trading Firm (General Partnership)551964379manufacture(75759-001)

Revised: 5/2020
Document Id: a534004b-fc14-3817-e053-2995a90a554d
Set id: a52c8654-eca1-ae58-e053-2995a90a5fb7
Version: 2
Effective Time: 20200508
 
Yiwu Pafa Trading Firm (General Partnership)