Truth Alcohol Free Hand Sanitizer - Unscented by LAB-CLEAN, INC

Truth Alcohol Free Hand Sanitizer - Unscented by

Drug Labeling and Warnings

Truth Alcohol Free Hand Sanitizer - Unscented by is a Otc medication manufactured, distributed, or labeled by LAB-CLEAN, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TRUTH ALCOHOL FREE HAND SANITIZER - UNSCENTED- benzalkonium chloride liquid 
LAB-CLEAN, 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.

----------

Active ingredient

Benzalkonium Chloride  0.13%

Purpose

Antimicrobial

Uses

For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use.

Warnings

For external use only.

When using this product, avoid contact with eyes. In case of eye contact flush eyes with water. Do not ingest.

Stop use and ask a doctor if irritation or redness develops, or if the condition persists for more than 72 hours.

Keep out of reach of children.

If swallowed, get medical help or  contact a Poison Control Center right away.

Directions

• Apply a small amount of product into the palm of hand. Rub thoroughly over all surfaces of both hands. Rub hands together briskly for 15 seconds until dry.

Inactive ingredients

Water, Cetrimonium Chloride, Laurtrimonium Chloride, Dihydroxyethyl Cocamine Oxide, Glycereth-17 Cocoate, Citric Acid.

Product label

TRUTH ALCOHOL FREE HAND SANITIZER - UNSCENTED 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73126-034
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)
DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)
GLYCERETH-17 COCOATE (UNII: 3057VPT0KC)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73126-034-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/04/2021
2	NDC: 73126-034-02	88 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/04/2021
3	NDC: 73126-034-03	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/04/2021
4	NDC: 73126-034-04	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/04/2021
5	NDC: 73126-034-05	474 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/04/2021
6	NDC: 73126-034-06	591 mL in 1 PACKAGE; Type 0: Not a Combination Product	03/04/2021
7	NDC: 73126-034-07	710 mL in 1 PACKAGE; Type 0: Not a Combination Product	03/04/2021
8	NDC: 73126-034-08	947 mL in 1 PACKAGE; Type 0: Not a Combination Product	03/04/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	03/04/2021	04/20/2024

Labeler - LAB-CLEAN, INC (199822219)

Establishment
Name	Address	ID/FEI	Business Operations
LAB-CLEAN, INC		199822219	manufacture(73126-034)

Revised: 4/2022

Document Id: dd944e02-8ce6-72e4-e053-2a95a90ae2fe

34390-5

Set id: 1c2d1d5d-9ba9-4839-be4f-c074a4e43498

Version: 2

Effective Time: 20220426