EVELINECHARLES PURE PURIFYING HAND CREAM MAX- alcohol cream 
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.

----------

Eveline Charles Pure Purifying Hand Cream Max

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

Alcohol 63% w/w. Purpose: Antimicrobial

Purpose

Antimicrobial, Purifying Hand Cream

Use

Eliminates bacteria and germs.

Warnings

Flammable. Keep away from open flame and sources of heat. This product is intended for external use only.

Do not use

Do not use in children less than 2 months of age and on open skin wounds.

When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop use if irritation or redness develops and consult a doctor.

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

Directions

Apply a small amount to hands and spread evenly.

Rub thoroughly into hands for at least 30 seconds.

Other information

Inactive ingredients

glycerin, purified water USP

Package Label - Principal Display Panel

60g NDC:76555-007-0160g NDC: 76555-007-01

EVELINECHARLES PURE PURIFYING HAND CREAM MAX 
alcohol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76555-007
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL37.8 g  in 60 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 0.29 g  in 60 g
PEG/PPG-18/12 DIMETHICONE (UNII: 2AY8NFX9E4) 5.1 g  in 60 g
WATER (UNII: 059QF0KO0R) 13.14 g  in 60 g
SODIUM ACRYLOYLDIMETHYLTAURATE (UNII: 2T9Q6EKI0G) 1.74 g  in 60 g
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9) 0.79 g  in 60 g
TOCOPHEROL (UNII: R0ZB2556P8) 0.06 g  in 60 g
2,6-DIMETHYL-5-HEPTENAL (UNII: Z331YX9EL9) 0.0012 g  in 60 g
3-CARENE (UNII: H2M15SNR6N) 0.0012 g  in 60 g
DIHYDROMYRCENOL (MIXED ISOMERS) (UNII: 7E6BIK8N98) 0.0036 g  in 60 g
ETHYL LINALOOL (UNII: SF2JS9GF5T) 0.0012 g  in 60 g
CEDRAMBER (UNII: 84S7T555CV) 0.0012 g  in 60 g
CYMENE (UNII: 830CI19HHD) 0.0012 g  in 60 g
LINALOOL, (+/-)- (UNII: D81QY6I88E) 0.0012 g  in 60 g
CYCLOMETHICONE (UNII: NMQ347994Z) 1.02 g  in 60 g
TETRAMETHYL ACETYLOCTAHYDRONAPHTHALENES (UNII: 2JU6ZH6GRE) 0.0072 g  in 60 g
.BETA.-PINENE (UNII: 4MS8VHZ1HJ) 0.0012 g  in 60 g
GERANIOL (UNII: L837108USY) 0.0012 g  in 60 g
METHYL IONONES (UNII: EL78BGX1LO) 0.0012 g  in 60 g
.ALPHA.-PINENE (UNII: JPF3YI7O34) 0.0012 g  in 60 g
PENTADECALACTONE (UNII: OK17S3S98K) 0.0012 g  in 60 g
BENZYL SALICYLATE (UNII: WAO5MNK9TU) 0.0024 g  in 60 g
DIHYDRO PENTAMETHYLINDANONE (UNII: BZR4438MY4) 0.0024 g  in 60 g
COUMARIN (UNII: A4VZ22K1WT) 0.0012 g  in 60 g
LINALYL ACETATE (UNII: 5K47SSQ51G) 0.0024 g  in 60 g
BOURGEONAL (UNII: H3XVS6E70V) 0.0012 g  in 60 g
2-TERT-BUTYLCYCLOHEXYL ACETATE (UNII: 364FV60913) 0.0024 g  in 60 g
LIMONENE, (+)- (UNII: GFD7C86Q1W) 0.0024 g  in 60 g
.GAMMA.-TERPINENE (UNII: 4YGF4PQP49) 0.0012 g  in 60 g
METHYL 3-METHYLORSELLINATE (UNII: 12YH9T04QE) 0.0012 g  in 60 g
ALLYL CYCLOHEXANEBUTYRATE (UNII: 9JIF47RD7B) 0.0012 g  in 60 g
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) 0.0012 g  in 60 g
3-(3,4-METHYLENEDIOXYPHENYL)-2-METHYLPROPANAL (UNII: L65EG8H6PA) 0.0024 g  in 60 g
AMBREIN (UNII: 1N9JB373FJ) 0.0012 g  in 60 g
CYCLOHEXANEPROPANOL, 2,2,6-TRIMETHYL-.ALPHA.-PROPYL- (UNII: CLV4EM4325) 0.0012 g  in 60 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76555-007-0160 g in 1 TUBE; Type 0: Not a Combination Product10/28/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/28/2021
Labeler - EC Labs Inc. (205510751)
Registrant - EC Labs Inc. (205510751)
Establishment
NameAddressID/FEIBusiness Operations
EC Labs Inc.205510751manufacture(76555-007) , pack(76555-007) , label(76555-007)

Revised: 10/2021
Document Id: cf70bb12-e90d-229b-e053-2995a90a2c9e
Set id: cf70cd1e-3738-4843-e053-2995a90a6f2d
Version: 1
Effective Time: 20211028
 
EC Labs Inc.