GEL HAND SANITIZER WINTERGREEN- alcohol gel
Sovents and Petroleum Inc

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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Wintergreen Scented Clean All Gel Hand Sanitizer

Active Ingredient(s)

Alcohol 65% Active ingredient

Purpose

Purpose Antiseptic, Hand Sanitizer

Use

To reduce bacteria on hands. Uses 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 Warnings

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

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, Inactive ingredients glycerin, hydrogen peroxide, polyethylene glycol, water

Questions

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

Package Label - Principal Display Panel

Front Label

GEL HAND SANITIZER WINTERGREEN
alcohol gel

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

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	10/13/2020

Labeler - Sovents and Petroleum Inc (013277454)

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