CHARCOAL FILTERED GEL HAND SANITIZER- alcohol gel
Solvents and Petroleum Service 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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Charcoal Filtered Clean All Gel Hand Sanitizer

Active Ingredient(s)

Active ingredient Alcohol 65%

Purpose

Purpose Antiseptic, Hand Sanitizer

Use

to reduce bacteria on hands, Uses . For use when soap and water are not available.

Warnings

Warnings For external use only. Flammable. Keep away from heat or flame

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

Keepout 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.
do not use on children less than 2 months old

Other information

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

Inactive ingredients

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

Inactive ingredients

Questions

1-800-315-4467 moday through friday 8am-5pm est Questions

Package Label - Principal Display Panel

Front panel

CHARCOAL FILTERED GEL HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:75660-154
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
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)	2 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)	30.96 mL in 100 mL
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)	0.01 mL in 100 mL

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:75660-154-01	3785.41 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/14/2020
2	NDC:75660-154-06	6 in 1 BOX	10/14/2020
2	NDC:75660-154-01	3785.41 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC:75660-154-04	4 in 1 BOX	10/14/2020
3	NDC:75660-154-01	3785.41 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4	NDC:75660-154-05	18927.05 mL in 1 CONTAINER; Type 0: Not a Combination Product	10/14/2020
5	NDC:75660-154-44	118.29 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/14/2020
6	NDC:75660-154-08	236.59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/14/2020
7	NDC:75660-154-16	473.17 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/14/2020
8	NDC:75660-154-25	9463.52 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/14/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	10/14/2020

Labeler - Solvents and Petroleum Service Inc (013277454)

Name	Address	ID/FEI	Business Operations
Establishment
Clean All		117505240	manufacture(75660-154)