ALCOHOL ANTISEPTIC - alcohol solution 
Natureplex 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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ALCOHOL ANTISEPTIC 80%
Topical

Drug Facts

Active ingredient[s]

Alcohol 80% v/v

Purpose

Antiseptic

Use[s]

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

Other information

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

PRINCIPAL DISPLAY PANEL - 3785.41 mL Jug Label

Natureplex Alcohol Antiseptic 80%
Topical Solution
NDC 67234-075-01

Hand Sanitizer
Non-sterile Solution

Natureplex, LLC
11085 Airport Rd Olive Branch, MS 38654
1-866-323-0107

Lot: XXXX
Part No: 3147

NATUREPLEX

1 gallon (3785.41 mL)

PRINCIPAL DISPLAY PANEL - 3785.41 mL Jug Label
ALCOHOL ANTISEPTIC  
alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67234-075
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:67234-075-013785.41 mL in 1 JUG; Type 0: Not a Combination Product03/27/2020
2NDC:67234-075-02208198 mL in 1 DRUM; Type 0: Not a Combination Product04/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart333E03/27/2020
Labeler - Natureplex LLC (062808196)
Establishment
NameAddressID/FEIBusiness Operations
Natureplex LLC062808196MANUFACTURE(67234-075)

Revised: 4/2020
Document Id: 1e3b3ab5-0fda-475f-8d51-8edbdbbcdcbe
Set id: 4786f832-6d43-4ca8-a4bd-9f53888ba13a
Version: 2
Effective Time: 20200403
 
Natureplex LLC