GEL HAND SANITIZER WINTERGREEN- alcohol gel

Gel Hand Sanitizer Wintergreen by

Drug Labeling and Warnings

Gel Hand Sanitizer Wintergreen by is a Otc medication manufactured, distributed, or labeled by Sovents and Petroleum Inc, Clean All. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Alcohol 65%

Purpose

Antiseptic, Hand Sanitizer

Use

To reduce bacteria on hands. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame, do not use on open wounds, avoid eyes, ears and mouth. In case of contact, rinse with water

Stop use and ask a doctor if irritation or rash occurs., you may report side effects 1-800-315-4467

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.
• Do not use on children less than two months of age
  

Other information

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

Inactive ingredients

acrylate polymer, bittering agent, fragrance, glycerin, hydrogen peroxide, polyethylene glycol, water

Questions

1-800-315-4467, Monday Through Friday 8am-5pm

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

GEL HAND SANITIZER WINTERGREEN 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75660-124
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	65 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) (UNII: 2N8MDB79NA)	0.5 mL  in 100 mL
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)	0.01 mL  in 100 mL
GAULTHERIA PROCUMBENS LEAF (UNII: 2125M16OWN)	0.01 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	1.35 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.18 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	30.95 mL  in 100 mL
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)	2 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75660-124-01	3785.41 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/13/2020
2	NDC: 75660-124-04	4 in 1 BOX	10/13/2020
2	NDC: 75660-124-01	3785.41 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC: 75660-124-05	18927.05 mL in 1 CONTAINER; Type 0: Not a Combination Product	10/13/2020
4	NDC: 75660-124-06	6 in 1 BOX	10/13/2020
4	NDC: 75660-124-01	3785.41 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
5	NDC: 75660-124-44	118.29 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/13/2020
6	NDC: 75660-124-08	236.59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/13/2020
7	NDC: 75660-124-16	473.17 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/13/2020
8	NDC: 75660-124-25	9463.52 mL in 1 CONTAINER; Type 0: Not a Combination Product	10/13/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	10/13/2020

Labeler - Sovents and Petroleum Inc (013277454)

Establishment
Name	Address	ID/FEI	Business Operations
Clean All		117505240	manufacture(75660-124)