REVIVE HAND SANITIZER - PROTECT- alcohol spray REVIVE HAND SANITIZER - IMMUNITY BOOST- alcohol spray REVIVE HAND SANITIZER - LAVENDER- isopropyl alcohol hand sanitizer spray

REVIVE Hand Sanitizer - Lavender by

Drug Labeling and Warnings

REVIVE Hand Sanitizer - Lavender by is a Otc medication manufactured, distributed, or labeled by TKS Co-Pack Manufacturing. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

• in children less than 2 months of age
• on open skin wounds

WHEN USING

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

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP, essential oil

Package Label - Principal Display Panel

30 mL NDC: 78266-005-01

30 mL NDC: 78266-004-01

30 mL NDC: 78266-006-01

INGREDIENTS AND APPEARANCE

REVIVE HAND SANITIZER - PROTECT 
alcohol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78266-009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	22.5 mL  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78266-009-01	30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	12/23/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	12/23/2020

REVIVE HAND SANITIZER - IMMUNITY BOOST 
alcohol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78266-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	22.5 mL  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78266-007-01	30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	12/23/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	12/23/2020

REVIVE HAND SANITIZER - LAVENDER 
isopropyl alcohol hand sanitizer spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78266-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	22.5 mL  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78266-008-01	30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	12/23/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	12/23/2020

Labeler - TKS Co-Pack Manufacturing (117172434)

Registrant - TKS Co-Pack Manufacturing (117172434)

Establishment
Name	Address	ID/FEI	Business Operations
TKS Co-Pack Manufacturing		117172434	manufacture(78266-007, 78266-008, 78266-009)