HAND SANITIZER- alcohol 70% gel 
Neoingenium Labs SA de CV

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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Hand Sanitizer

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 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

To decrease bacteria on the skin that could cause desease. Recommennded for repeated use.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

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.

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

Aqua, glycerin, Carbomer, Aloe Barbadensis Leaf Extract, Triethanolamine, Propylen Glycol, EDTA Disodium Salt

Package Label - Principal Display Panel

500 ml label500 mL NDC: 75810-101-01

Label

HAND SANITIZER 
alcohol 70% gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75810-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
EDETIC ACID (UNII: 9G34HU7RV0) 0.09 g  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.46 g  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 0.46 g  in 100 mL
CARBOMER 940 (UNII: 4Q93RCW27E) 0.46 g  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK) 0.23 g  in 100 mL
WATER (UNII: 059QF0KO0R) 25.94 g  in 100 mL
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75810-101-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/01/2020
Labeler - Neoingenium Labs SA de CV (951576661)
Registrant - Neoingenium Labs SA de CV (951576661)
Establishment
NameAddressID/FEIBusiness Operations
Neoingenium Labs SA de CV951576661manufacture(75810-101)

Revised: 4/2020
Document Id: a45d163d-2fe8-1ac5-e053-2995a90adb07
Set id: a45d1d10-6a67-55cc-e053-2995a90a1f91
Version: 1
Effective Time: 20200428
 
Neoingenium Labs SA de CV