PERCNT HAND SANITIZER - LAVENDER ALCOHOL GEL- alcohol gel 
PERCNT HAND SANITIZER - LEMON ALCOHOL GEL- alcohol gel 
PERCNT BULK HAND SANITIZER - UNSCENTED ALCOHOL GEL- alcohol gel 
Percnt

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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Lavender, Lemon & Bulk Gel

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. Lavender Oil (0.10% v/v).
  5. Methylcellulose
  6. 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, Lavender oil, Methylcellulose, purified water USP

Lavender

Lavender NDC:79132-001

Bulk Unscented

Bulk Unscented NDC:79132-100

Lemon

Lemon NDC:79132-002

PERCNT HAND SANITIZER - LAVENDER ALCOHOL GEL 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79132-001
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) 1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
LAVENDER OIL (UNII: ZBP1YXW0H8) 0.1 mL  in 100 mL
METHYLCELLULOSE, UNSPECIFIED (UNII: Z944H5SN0H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79132-001-08250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/05/2020
2NDC:79132-001-16500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/05/2020
3NDC:79132-001-011003133.65 mL in 1 TANK; Type 0: Not a Combination Product08/26/2020
4NDC:79132-001-0026497870 mL in 1 TANK; Type 0: Not a Combination Product08/26/2020
5NDC:79132-001-0262.5 mL in 1 BOTTLE; Type 0: Not a Combination Product08/05/2020
6NDC:79132-001-04125 mL in 1 BOTTLE; Type 0: Not a Combination Product08/05/2020
7NDC:79132-001-32946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/05/2020
8NDC:79132-001-123785.4 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/05/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/05/2020
PERCNT HAND SANITIZER - LEMON ALCOHOL GEL 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79132-002
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) 1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
METHYLCELLULOSE, UNSPECIFIED (UNII: Z944H5SN0H)  
LEMON OIL (UNII: I9GRO824LL) 0.05 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79132-002-08250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/05/2020
2NDC:79132-002-16500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/05/2020
3NDC:79132-002-011003133.65 mL in 1 TANK; Type 0: Not a Combination Product08/26/2020
4NDC:79132-002-0026497870 mL in 1 TANK; Type 0: Not a Combination Product08/26/2020
5NDC:79132-002-0262.5 mL in 1 BOTTLE; Type 0: Not a Combination Product08/05/2020
6NDC:79132-002-04125 mL in 1 BOTTLE; Type 0: Not a Combination Product08/05/2020
7NDC:79132-002-123785.4 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/05/2020
8NDC:79132-002-32946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/05/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/05/2020
PERCNT BULK HAND SANITIZER - UNSCENTED ALCOHOL GEL 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79132-100
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) 1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
METHYLCELLULOSE, UNSPECIFIED (UNII: Z944H5SN0H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79132-100-011003133.65 mL in 1 TANK; Type 0: Not a Combination Product09/08/2020
2NDC:79132-100-0026497870 mL in 1 TANK; Type 0: Not a Combination Product09/08/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/08/2020
Labeler - Percnt (117553408)
Establishment
NameAddressID/FEIBusiness Operations
Percnt117553408manufacture(79132-100, 79132-001, 79132-002)

Revised: 10/2020
Document Id: b0f0513c-2972-401b-e053-2995a90a313b
Set id: ac142bef-f6e0-5e99-e053-2a95a90a9811
Version: 2
Effective Time: 20201005
 
Percnt