EC PURE INSTANT CREAM HAND SANITIZER ZEN- alcohol cream

EC Pure Instant Cream Hand Sanitizer Zen by

Drug Labeling and Warnings

EC Pure Instant Cream Hand Sanitizer Zen by is a Otc medication manufactured, distributed, or labeled by Ec Labs Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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 use only.

Do not use

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

WHEN USING

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

STOP USE

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

KEEP OUT OF REACH OF CHILDREN

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 lease 30 secconds.

Allow to dry.

For occasional and personal use.

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

Other information

• Store between 59-86F
• Avoid freezing and excessive heat above104F

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

60g NDC: 76555-005-01

INGREDIENTS AND APPEARANCE

EC PURE INSTANT CREAM HAND SANITIZER ZEN 
alcohol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76555-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	37.8 g  in 60 g

Inactive Ingredients
Ingredient Name	Strength
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)	0.78 g  in 60 g
MANDARIN OIL (UNII: NJO720F72R)	0.0048 g  in 60 g
ORANGE OIL (UNII: AKN3KSD11B)	0.0744 g  in 60 g
LEMON OIL (UNII: I9GRO824LL)	0.0036 g  in 60 g
CYCLOMETHICONE (UNII: NMQ347994Z)	1.02 g  in 60 g
PEG/PPG-18/12 DIMETHICONE (UNII: 2AY8NFX9E4)	5.1 g  in 60 g
SODIUM ACRYLOYLDIMETHYLTAURATE (UNII: 2T9Q6EKI0G)	1.74 g  in 60 g
LAVENDER OIL (UNII: ZBP1YXW0H8)	0.00132 g  in 60 g
POGOSTEMON CABLIN LEAF OIL (UNII: F3IN55X5PO)	0.0064 g  in 60 g
CITRUS NOBILIS (UNII: 8MFF77J91V)	0.0024 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)	13.09 g  in 60 g
ROSEWOOD OIL (UNII: F2522O5L7B)	0.00192 g  in 60 g
CITRUS AURANTIUM FLOWER OIL (UNII: D4BGE91OXH)	0.0064 g  in 60 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76555-005-01	60 g in 1 TUBE; Type 0: Not a Combination Product	07/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/31/2020

Labeler - Ec Labs Inc (205510751)

Registrant - Ec Labs Inc (205510751)

Establishment
Name	Address	ID/FEI	Business Operations
Ec Labs Inc		205510751	manufacture(76555-005) , pack(76555-005) , sterilize(76555-005)