Hand Sanitizer Gel by Flotek Chemistry, LLC / Flotek Industries, Inc

Hand Sanitizer Gel by

Drug Labeling and Warnings

Hand Sanitizer Gel by is a Otc medication manufactured, distributed, or labeled by Flotek Chemistry, LLC, Flotek Industries, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER GEL- 70% isopropyl alcohol gel hand sanitizer gel 
Flotek Chemistry, LLC

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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Active Ingredient[s]

Isopropyl alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use[s]

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Health Care personnel hand rub to help reduce bacteria that potentially can cause disease.

Warnings

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

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 signes of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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).

Avoid exposure to sunlight or UV light.

Inactive Ingredients

Glycerin, Carbomer, water, diisopropanolamine, alpha-tocopherol acetate, aloe barbadensis

Package labeling- Principal Display Panel

NDC: 74208-370-07 1249.19 L (330gal)

1 GAL. (3.785L) NDC: 74208-370-01

32 FL OZ. (946 ML) NDC: 74208-370-03

16 FL OZ. (473.2 ML) NDC: 74208-370-09

8 FL OZ. (236.5 ML) NDC: 74208-370-05

4 FL OZ. (118.3 ML) NDC: 74208-370-20

2 FL OZ. (59.15 ML) NDC: 74208-370-18

HAND SANITIZER GEL 
70% isopropyl alcohol gel hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74208-370
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	70 L  in 100 L

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	27.64 L  in 100 L
GLYCERIN (UNII: PDC6A3C0OX)	1.47 L  in 100 L
ALOE (UNII: V5VD430YW9)	0.0081 L  in 100 L
CARBOMER 940 (UNII: 4Q93RCW27E)	0.25 kg  in 100 L
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)	0.0008 L  in 100 L
DIISOPROPANOLAMINE (UNII: 0W44HYL8T5)	0.171 L  in 100 L

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74208-370-01	3.78 L in 1 JUG; Type 0: Not a Combination Product	05/31/2020	03/31/2022
2	NDC: 74208-370-02	15.14 L in 1 CASE; Type 0: Not a Combination Product	05/31/2020	03/31/2022
3	NDC: 74208-370-03	0.95 L in 1 BOTTLE; Type 0: Not a Combination Product	05/31/2020	03/31/2022
4	NDC: 74208-370-04	11.36 L in 1 BOTTLE; Type 0: Not a Combination Product	05/31/2020	03/31/2022
5	NDC: 74208-370-05	0.237 L in 1 BOTTLE; Type 0: Not a Combination Product	05/31/2020	03/31/2022
6	NDC: 74208-370-06	1.42 L in 1 CASE; Type 0: Not a Combination Product	05/31/2020	03/31/2022
7	NDC: 74208-370-07	1249.19 L in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product	05/31/2020	03/31/2022
8	NDC: 74208-370-18	0.05915 L in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2021	01/01/2022
9	NDC: 74208-370-20	0.1183 L in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2021	01/01/2022
10	NDC: 74208-370-09	0.473 L in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2021	03/31/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/31/2020	06/30/2022

Labeler - Flotek Chemistry, LLC (116701044)

Registrant - Flotek Industries, Inc (159997535)

Establishment
Name	Address	ID/FEI	Business Operations
Flotek Chemistry, LLC		118445793	manufacture(74208-370)

Revised: 8/2022

Document Id: e76e941c-1b16-4bb0-e053-2995a90a7d2c

34390-5

Set id: a75ebe34-c31a-dfef-e053-2995a90a96b8

Version: 5

Effective Time: 20220830