CLEAN AND PURE HAND SANITIZER GEL- alcohol gel 
EVESEL 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.

----------

Clean & Pure Hand Sanitizer Gel

Active Ingredient(s)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

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

Water, Butylene Glycol, Carbomer, Triethanolamine, perfume, Polysorbate 60, DL-Panthenol

Package Label - Principal Display Panel

Alcohol 70%

Clean & Pure

Hand Sanitizer Gel

Kills more than 99.9% of Germs

Alcohol Antiseptic 70%

Topical Solution

Effective Inhibition

non-sterile solution

Improved formula

500 mL / 16 fl.oz.

100ml

300ml

120ml

60ml

clean and pure label

CLEAN AND PURE HAND SANITIZER GEL 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78146-701
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
CARBOMER 940 (UNII: 4Q93RCW27E) 0.45 mL  in 100 mL
POLYSORBATE 60 (UNII: CAL22UVI4M) 0.01 mL  in 100 mL
PANTHENOL (UNII: WV9CM0O67Z) 0.01 mL  in 100 mL
BUTANEDIOL (MIXED ISOMERS) (UNII: TMS4MGA0H4) 2.5 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK) 0.08 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78146-701-50500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
2NDC:78146-701-103785 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
3NDC:78146-701-6060 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
4NDC:78146-701-12120 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
5NDC:78146-701-30300 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
6NDC:78146-701-111000 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 - EVESEL CO., LTD. (689533479)
Establishment
NameAddressID/FEIBusiness Operations
EVESEL CO., LTD.689533479manufacture(78146-701)

Revised: 1/2021
Document Id: b878d71c-dfe7-100f-e053-2995a90af42f
Set id: a6227706-76bb-be60-e053-2a95a90a72ec
Version: 5
Effective Time: 20210109
 
EVESEL CO., LTD.