Enviropure by Span Packaging Services LLC Enviropure

Enviropure by

Drug Labeling and Warnings

Enviropure by is a Otc medication manufactured, distributed, or labeled by Span Packaging Services LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ENVIROPURE- alcohol solution 
Span Packaging Services LLC

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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Enviropure

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 80% v/v. Purpose: Antiseptic

Purpose

Antiseptic

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

  • in children less than 2 months of age
  • on open skin wounds

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

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

image description

image description

ENVIROPURE 
alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 55049-054
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 55049-054-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product11/12/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A11/12/2020
Labeler - Span Packaging Services LLC (557434805)
Establishment
NameAddressID/FEIBusiness Operations
Span Packaging Services LLC557434805manufacture(55049-054) , pack(55049-054) , label(55049-054)

Revised: 7/2022
 

Trademark Results [Enviropure]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ENVIROPURE
ENVIROPURE
97723185 not registered Live/Pending
GLOBAL WATER PURIFICATION LLC
2022-12-19
ENVIROPURE
ENVIROPURE
97355985 not registered Live/Pending
AIRGLE CORPORATION
2022-04-10
ENVIROPURE
ENVIROPURE
87901340 not registered Dead/Abandoned
Water, Inc.
2018-04-30
ENVIROPURE
ENVIROPURE
85565344 not registered Dead/Abandoned
TIFCO INDUSTRIES, INC.
2012-03-09
ENVIROPURE
ENVIROPURE
76720321 not registered Dead/Abandoned
water, inc.
2017-08-01
ENVIROPURE
ENVIROPURE
76685861 not registered Dead/Abandoned
WATER, INC.
2008-01-17
ENVIROPURE
ENVIROPURE
76186470 not registered Dead/Abandoned
Marcus Group, Inc., The
2000-12-27
ENVIROPURE
ENVIROPURE
74651604 1990938 Dead/Cancelled
WATER, INC.
1995-03-27
ENVIROPURE
ENVIROPURE
74322872 1810559 Live/Registered
HMI INDUSTRIES INC.
1992-10-16
ENVIROPURE
ENVIROPURE
74242216 1721315 Dead/Cancelled
ENVIROPURE INC.
1992-02-03
ENVIROPURE
ENVIROPURE
74011333 1623173 Dead/Cancelled
RAINES, ERROL
1989-12-14

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