Hand Sanitizer by Current Lighting Solutions, LLC

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Current Lighting Solutions, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER- alcohol gel 
Current Lighting Solutions, 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)

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 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.

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

glycerin, acrylates/vinyl neodecanoate crosspolymer, aminomethylpropanol, hydrogen peroxide, water

Package Label - Principal Display Panel

3785 mL NDC: 74539-020-02

450 mL NDC: 74539-020-03

236 mL NDC: 74539-020-04

18927 mL NDC: 74539-020-05

56781 mL NDC: 74539-020-06

208198 mL NDC: 74539-020-07

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74539-020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)	0.11 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.12 mL  in 100 mL
WATER (UNII: 059QF0KO0R)
ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) (UNII: 2N8MDB79NA)	1.17 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74539-020-02	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/14/2020
2	NDC: 74539-020-03	450 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/14/2020
3	NDC: 74539-020-04	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/14/2020
4	NDC: 74539-020-05	18927 mL in 1 DRUM; Type 0: Not a Combination Product	09/14/2020
5	NDC: 74539-020-06	56781 mL in 1 DRUM; Type 0: Not a Combination Product	09/14/2020
6	NDC: 74539-020-07	208198 mL in 1 DRUM; Type 0: Not a Combination Product	09/14/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/14/2020	11/30/2021

Labeler - Current Lighting Solutions, LLC (045163688)

Establishment
Name	Address	ID/FEI	Business Operations
Current Lighting Solutions, LLC		045163688	manufacture(74539-020)

Revised: 12/2021

Document Id: d2820f61-39b6-259c-e053-2a95a90a4196

34390-5

Set id: ac8d13f9-8654-da3d-e053-2995a90aac05

Version: 3

Effective Time: 20211206