Active Ingredient(s)

Alcohol 70% 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 ingest or inhale.

Do not use

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

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.

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

Fragrance (Parfum), Glycerin, Isopropyl Myristate, Polyethylene Glycol/Acrylates Copolymer, Tocopheryl Acetate, Water

945.35mL NDC: 75594-071-09 AmeriClean 32oz Label

1.89L NDC: 75594-071-10 AmeriClean 64oz Label

3.78L NDC: 75594-071-11 AmeriClean Gallon Label

237mL NDC: 75594-071-01 Modern Chem 8oz

354mL NDC:75594-071-03 Modern Chem 16 oz

946mL NDC: 75594-071-04 Modern Chem 32oz

1.89L NDC: 75594-071-05 Modern Chem 64oz

3.78L NDC: 75594-071-06 Modern Chemical Gallon

208.198L NDC: 75594-071-07 Modern Chem Aloe Drum

354mL NDC: 75594-071-16 Intergrity Aloe

237mL NDC: 75594-071-17 Modern Chem 8oz Flip

59ml NDC: 75594-071-18

2oz Premium Label

118ml NDC: 75594-071-19

4oz Premium Label

237ml NDC: 75594-071-20

8oz Premium Label

355ml NDC: 75594-071-21

12oz Premium Label

473ml NDC: 75594-071-22 16oz Premium Label

946ml NDC: 75594-071-23

32oz Premium Label 1.89L NDC: 75594-071-24

64oz Premium Label 3.78L NDC: 75594-071-25

128oz Premium Label

ALOE GEL
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:75594-071(NDC:74221-004)
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 L in 1 L

Ingredient Name	Strength
Inactive Ingredients
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
RAPIDGEL EZ1 (UNII: 33JH4A7R2K)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:75594-071-09	0.94635 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/23/2020
2	NDC:75594-071-10	1.89 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/23/2020
3	NDC:75594-071-11	3.78 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/23/2020
4	NDC:75594-071-01	0.237 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/23/2020
5	NDC:75594-071-03	0.473 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/23/2020
6	NDC:75594-071-04	0.946 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/23/2020
7	NDC:75594-071-05	1.89 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/23/2020
8	NDC:75594-071-06	3.78 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/23/2020
9	NDC:75594-071-07	208.198 L in 1 DRUM; Type 0: Not a Combination Product	07/23/2020
10	NDC:75594-071-16	0.354 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/23/2020
11	NDC:75594-071-17	0.237 L in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	07/23/2020
12	NDC:75594-071-18	0.59 L in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	07/23/2020
13	NDC:75594-071-19	0.118 L in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	07/23/2020
14	NDC:75594-071-20	0.237 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/23/2020
15	NDC:75594-071-21	0.355 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/23/2020
16	NDC:75594-071-22	0.473 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/23/2020
17	NDC:75594-071-23	0.946 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/23/2020
18	NDC:75594-071-24	1.89 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/23/2020
19	NDC:75594-071-25	3.78 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/23/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	07/23/2020

Labeler - Commercial Beverage Concepts, LLC (080925174)

Name	Address	ID/FEI	Business Operations
Establishment
Commercial Beverage Concepts, LLC		080925174	pack(75594-071) , repack(75594-071) , label(75594-071) , relabel(75594-071)