EVELINE CHARLES HAND SANITIZER- alcohol gel 
Ec Labs Inc

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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Eveline Charles Hand Sanitizerr

Hand sanitize eliminates bacteria, germs and viruses. Skin softening formula features aloe vera and glycerin for hydration and protection.

Active Ingredient(s)

Alcohol 72% w/w. Purpose: Antimicrobial

Purpose

Hand Sanitizer.

Use

Hand Sanitizer to kill harmful germs/bacteria/viruses. For use when soap and water are not available.

Warnings

For external use only

Flammability warning. Keep away from open flame and sources of heat
When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.
Stop use and ask/ consult a doctor/ physician/ health care practitioner/ health care provider/ health care professional if irritation develops.
Keep out of reach of children. If swallowed, call a poison control centre or get medical help right away.

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.

Directions

Other information

Inactive ingredients

glycerin, carbomer, triethanolamine, aloe, purified water USP

60g label60g NDC: 76555-001-01

240g NDC: 76555-001-02 240g label

296g NDC: 76555-001-03 296g label

500g NDC: 76555-001-04 500g label

750g NDC: 76555-001-05

1kg NDC:76555-001-06

4kg NDC:76555-001-07 4 kg label1 kg label750 g label

EVELINE CHARLES HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76555-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL72 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 2 g  in 100 g
ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.05 g  in 100 g
WATER (UNII: 059QF0KO0R) 25.15 g  in 100 g
CARBOMER 940 (UNII: 4Q93RCW27E) 0.55 g  in 100 g
TROLAMINE (UNII: 9O3K93S3TK) 0.25 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76555-001-0160 g in 1 BOTTLE; Type 0: Not a Combination Product06/05/2020
2NDC:76555-001-02240 g in 1 BOTTLE; Type 0: Not a Combination Product06/05/2020
3NDC:76555-001-03296 g in 1 BOTTLE; Type 0: Not a Combination Product06/05/2020
4NDC:76555-001-04500 g in 1 BOTTLE; Type 0: Not a Combination Product06/05/2020
5NDC:76555-001-05750 g in 1 BOTTLE; Type 0: Not a Combination Product06/05/2020
6NDC:76555-001-061000 g in 1 BOTTLE; Type 0: Not a Combination Product06/05/2020
7NDC:76555-001-074000 g in 1 JUG; Type 0: Not a Combination Product06/05/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/05/2020
Labeler - Ec Labs Inc (205510751)
Registrant - Ec Labs Inc (205510751)
Establishment
NameAddressID/FEIBusiness Operations
Ec Labs Inc205510751manufacture(76555-001) , pack(76555-001) , label(76555-001)

Revised: 6/2020
Document Id: a356c99e-9386-36e2-e053-2a95a90a2b45
Set id: a356d680-b5c3-4219-e053-2a95a90a98d1
Version: 1
Effective Time: 20200605
 
Ec Labs Inc