EC PURE INSTANT CREAM HAND SANITIZER LOVE- 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.

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Eveline Charles Pure Instant Cream Hand Sanitizer Love

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, Hand Sanitizer

Use

Eliminates bacteria and germs.

Warnings

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

Do not use

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

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

Stop use if irritation or redness develops. stop use 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.

Allow to dry.

For occassional and personal use.

Supervise children under 6 years of age when using this product.

Other information

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

love label60 g NDC: 76555-004-01

EC PURE INSTANT CREAM HAND SANITIZER LOVE 
alcohol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76555-004
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
SODIUM ACRYLOYLDIMETHYLTAURATE (UNII: 2T9Q6EKI0G) 1.74 g  in 60 g
GLYCERIN (UNII: PDC6A3C0OX) 0.3 g  in 60 g
TOCOPHEROL (UNII: R0ZB2556P8) 0.06 g  in 60 g
WATER (UNII: 059QF0KO0R) 13.15 g  in 60 g
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9) 0.78 g  in 60 g
CYCLOMETHICONE (UNII: NMQ347994Z) 1.02 g  in 60 g
SANDALWOOD OIL (UNII: X7X01WMQ5F) 0.007 g  in 60 g
CITRUS AURANTIUM FLOWER OIL (UNII: D4BGE91OXH) 0.0122 g  in 60 g
POGOSTEMON CABLIN LEAF OIL (UNII: F3IN55X5PO) 0.0034 g  in 60 g
LAVENDER OIL (UNII: ZBP1YXW0H8) 0.0072 g  in 60 g
PEG/PPG-18/12 DIMETHICONE (UNII: 2AY8NFX9E4) 5.1 g  in 60 g
STYRAX TONKINENSIS RESIN (UNII: QB299X2IBD) 0.0068 g  in 60 g
ROSE OIL (UNII: WUB68Y35M7) 0.0068 g  in 60 g
MANDARIN OIL (UNII: NJO720F72R) 0.0084 g  in 60 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76555-004-0160 g in 1 TUBE; Type 0: Not a Combination Product07/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/31/2020
Labeler - Ec Labs Inc (205510751)
Registrant - Ec Labs Inc (205510751)
Establishment
NameAddressID/FEIBusiness Operations
Ec Labs Inc205510751manufacture(76555-004) , pack(76555-004) , label(76555-004)

Revised: 1/2022
Document Id: d58d711c-4d0c-0184-e053-2a95a90aded4
Set id: ac131c27-57a6-473d-e053-2a95a90a7f2e
Version: 2
Effective Time: 20220114
 
Ec Labs Inc