HAND SANITIZER- alcohol gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Solents and Petroleum Service INC, Clean All. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Purpose

Purpose... Antiseptic

Use

Uses

to reduce bacteria on hands

when soap and water are not available

Warnings

Warnings

Stop and ask doctor if

Stop and ask doctor if

irriation or rash occurs

you may report side effects to 1-800-315-4467

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.

Other information

Store between 15-30C (59-86F)
Avoid freezing 32 F (0 C)
Avoid excessive heat above 140 F (40 C)

Inactive ingredients

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

Directions

Directions
Place enough product on hands to cover all areas
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

Questions?

Questions? 1-800-315-4467 Monday through Friday 8am to 5pm ES

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75660-054
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	2460.52 mL  in 3785.41 mL

Inactive Ingredients
Ingredient Name	Strength
ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) (UNII: 2N8MDB79NA)	18.93 mL  in 3785.41 mL
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)	0.38 mL  in 3785.41 mL
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)	75.71 mL  in 3785.41 mL
GLYCERIN (UNII: PDC6A3C0OX)	51.1 mL  in 3785.41 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	6.81 mL  in 3785.41 mL
WATER (UNII: 059QF0KO0R)	1172.34 mL  in 3785.41 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75660-054-04	4 in 1 BOX	09/01/2020
1	NDC: 75660-054-01	3785.41 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 75660-054-05	18927.05 mL in 1 CONTAINER; Type 0: Not a Combination Product	04/30/2020
3	NDC: 75660-054-44	118.29 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	04/30/2020
4	NDC: 75660-054-08	239.58 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	04/30/2020
5	NDC: 75660-054-16	473.17 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	04/30/2020
6	NDC: 75660-054-25	9463.52 mL in 1 CONTAINER; Type 0: Not a Combination Product	04/30/2020
7	NDC: 75660-054-01	3785.41 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/30/2020
8	NDC: 75660-054-06	6 in 1 BOX	03/30/2020
8	NDC: 75660-054-01	3785.41 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/01/2020

Labeler - Solents and Petroleum Service INC (013277454)

Establishment
Name	Address	ID/FEI	Business Operations
Clean All		117505240	manufacture(75660-054)