REVIVE HAND SANITIZER - PROTECT- alcohol spray 
REVIVE HAND SANITIZER - IMMUNITY BOOST- alcohol spray 
REVIVE HAND SANITIZER - LAVENDER- isopropyl alcohol hand sanitizer spray 
TKS Co-Pack Manufacturing

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. Ethyl Alcohol (75%, v/v) in an aqueous solution denatured 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.
  5. Essential oil as fragrance (5.0% v/v)

Active Ingredient(s)

Isopropyl Alcohol 75% 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, essential oil

Package Label - Principal Display Panel

30 mL NDC: 78266-005-01

30 mL NDC: 78266-005-01

30 mL NDC: 78266-004-01

30 mL NDC: 78266-004-01

30 mL NDC: 78266-006-01

30 mL NDC: 78266-006-01

REVIVE HAND SANITIZER - PROTECT 
alcohol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78266-009
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL22.5 mL  in 30 mL
Inactive Ingredients
Ingredient NameStrength
CINNAMON BARK OIL (UNII: XE54U569EC) 0.535 mL  in 30 mL
CLOVE OIL (UNII: 578389D6D0) 0.322 mL  in 30 mL
GLYCERIN (UNII: PDC6A3C0OX) 0.623 mL  in 30 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.05 mL  in 30 mL
WATER (UNII: 059QF0KO0R) 5.219 mL  in 30 mL
CITRUS SINENSIS FRUIT OIL (UNII: WV48LBL15Q) 0.267 mL  in 30 mL
EUCALYPTUS OIL (UNII: 2R04ONI662) 0.267 mL  in 30 mL
ROSMARINUS OFFICINALIS FLOWERING TOP OIL (UNII: OXN0D3N28L) 0.267 mL  in 30 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78266-009-0130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product12/23/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A12/23/2020
REVIVE HAND SANITIZER - IMMUNITY BOOST 
alcohol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78266-007
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL22.5 mL  in 30 mL
Inactive Ingredients
Ingredient NameStrength
CINNAMON BARK OIL (UNII: XE54U569EC) 0.322 mL  in 30 mL
CLOVE OIL (UNII: 578389D6D0) 0.322 mL  in 30 mL
GLYCERIN (UNII: PDC6A3C0OX) 0.623 mL  in 30 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.05 mL  in 30 mL
WATER (UNII: 059QF0KO0R) 5.217 mL  in 30 mL
CITRUS LIMON SEED OIL (UNII: T78Z8273XO) 0.322 mL  in 30 mL
EUCALYPTUS OIL (UNII: 2R04ONI662) 0.322 mL  in 30 mL
ROSMARINUS OFFICINALIS FLOWERING TOP OIL (UNII: OXN0D3N28L) 0.322 mL  in 30 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78266-007-0130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product12/23/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A12/23/2020
REVIVE HAND SANITIZER - LAVENDER 
isopropyl alcohol hand sanitizer spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78266-008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL22.5 mL  in 30 mL
Inactive Ingredients
Ingredient NameStrength
LAVENDER OIL (UNII: ZBP1YXW0H8) 1.6 mL  in 30 mL
GLYCERIN (UNII: PDC6A3C0OX) 0.62 mL  in 30 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.05 mL  in 30 mL
WATER (UNII: 059QF0KO0R) 5.2 mL  in 30 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78266-008-0130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product12/23/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A12/23/2020
Labeler - TKS Co-Pack Manufacturing (117172434)
Registrant - TKS Co-Pack Manufacturing (117172434)
Establishment
NameAddressID/FEIBusiness Operations
TKS Co-Pack Manufacturing117172434manufacture(78266-007, 78266-008, 78266-009)

Revised: 12/2020
Document Id: b727b7fb-80b9-607a-e053-2a95a90af1a6
Set id: ac15580f-7eb1-1bdb-e053-2995a90a7eb6
Version: 4
Effective Time: 20201223
 
TKS Co-Pack Manufacturing