HAND SANITIZER- alcohol liquid 
Nancy's Passions 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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80% Alcohol Hand Sanitizer Spray Topical Antiseptic Non-Sterile

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, Hand Sanitizer

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

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

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

80% Alcohol Hand Sanitizer50 mL NDC: 80078-001-03

Topical Spray Solution
Alcohol Antiseptic
Hand Sanitizer
80% Alcohol
Non-sterile

The image shows the front panel of the pouch. It is manufactured in California by me. The rear has the drug facts and pertinent information. Inside the pouch, there is the product that also has the appropriate label and all info (front and back). I am using a pouch as a security feature.

HAND SANITIZER 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80078-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.013 mL  in 100 mL
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T) 0.005 mL  in 100 mL
LAVENDER OIL (UNII: ZBP1YXW0H8) 0.02 mL  in 100 mL
SPEARMINT OIL (UNII: C3M81465G5) 0.01 mL  in 100 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 8.431 mL  in 100 mL
2-AMINO-1,3-PROPANEDIOL (UNII: IC94L30J8M) 2.418 mL  in 100 mL
BENZYL ALCOHOL (UNII: LKG8494WBH) 0.0278 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 0.581 mL  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X) 28.5158 mL  in 100 mL
RHODIOLA ROSEA ROOT (UNII: 3S5ITS5ULN) 0.013 mL  in 100 mL
VACCINIUM ANGUSTIFOLIUM WHOLE (UNII: R3538BZ1BW) 0.013 mL  in 100 mL
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) 0.022 mL  in 100 mL
BUTYLENE GLYCOL (UNII: 3XUS85K0RA) 3.2833 mL  in 100 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.332 mL  in 100 mL
SAGE OIL (UNII: U27K0H1H2O) 0.02 mL  in 100 mL
XANTHAN GUM (UNII: TTV12P4NEE) 0.066 mL  in 100 mL
PANTHENOL (UNII: WV9CM0O67Z) 0.8165 mL  in 100 mL
HYALURONATE SODIUM (UNII: YSE9PPT4TH) 0.022 mL  in 100 mL
DECYL GLUCOSIDE (UNII: Z17H97EA6Y) 0.022 mL  in 100 mL
COCO GLUCOSIDE (UNII: ICS790225B) 0.017 mL  in 100 mL
SODIUM HYDROXYMETHYLGLYCINATE (UNII: DIG6BWZ9XT) 0.004 mL  in 100 mL
POLYSORBATE 20 (UNII: 7T1F30V5YH) 0.173 mL  in 100 mL
LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y) 0.0545 mL  in 100 mL
LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U) 0.0545 mL  in 100 mL
ROSA DAMASCENA FLOWER OIL (UNII: 18920M3T13) 0.035 mL  in 100 mL
BETAINE (UNII: 3SCV180C9W) 0.026 mL  in 100 mL
WITCH HAZEL (UNII: 101I4J0U34) 0.01 mL  in 100 mL
CEDRUS ATLANTICA BARK OIL (UNII: ZX5QRE4U60) 0.1 mL  in 100 mL
VANILLA PLANIFOLIA OIL (UNII: 0A3F415158) 0.06 mL  in 100 mL
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80078-001-031 in 1 POUCH12/10/2020
150 mL in 1 BOTTLE, SPRAY; Type 1: Convenience Kit of Co-Package
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A11/26/2020
Labeler - Nancy's Passions LLC (080236251)
Registrant - Nancy's Passions LLC (080236251)
Establishment
NameAddressID/FEIBusiness Operations
Nancy's Passions LLC080236251manufacture(80078-001)

Revised: 11/2020
Document Id: b4ceb6af-f7b0-ad59-e053-2a95a90afd22
Set id: b4ceb643-26df-0404-e053-2a95a90a54c6
Version: 1
Effective Time: 20201126
 
Nancy's Passions LLC