SPA SENSE ANTIBACTERIAL HAND WASH by LAB-CLEAN, INC

SPA SENSE ANTIBACTERIAL HAND WASH by

Drug Labeling and Warnings

SPA SENSE ANTIBACTERIAL HAND WASH by is a Otc medication manufactured, distributed, or labeled by LAB-CLEAN, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPA SENSE ANTIBACTERIAL HAND WASH- 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.

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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 and conditions persist.

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

Directions

Apply small amount of product to wet hands. Work into lather and rinse thoroughly. Dry hands.

Inactive ingredients

Water, Cocamidopropyl Betaine, PEG 150 Distearate, Caprylyl Glucoside, Glycerine, Cocamide MIPA, Tetrasodium EDTA, Citric Acid, Aloe Vera, Benzisothiazol, Methylisathiozol

Product Label

SPA SENSE ANTIBACTERIAL HAND WASH 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73126-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)
CAPRYLYL GLUCOSIDE (UNII: V109WUT6RL)
GLYCERIN (UNII: PDC6A3C0OX)
COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)
EDETATE SODIUM (UNII: MP1J8420LU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BENZISOTHIAZOLINONE (UNII: HRA0F1A4R3)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73126-010-01	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020
2	NDC: 73126-010-02	474 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020
3	NDC: 73126-010-03	502 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020
4	NDC: 73126-010-04	532 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020
5	NDC: 73126-010-05	710 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020
6	NDC: 73126-010-06	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/01/2020	04/20/2024

Labeler - LAB-CLEAN, INC (199822219)

Establishment
Name	Address	ID/FEI	Business Operations
LAB-CLEAN, INC		199822219	manufacture(73126-010)

Revised: 4/2022

Document Id: dd93d53d-5495-b47c-e053-2a95a90a2a05

34390-5

Set id: 90381804-2478-4506-a9cb-a7fb371fc2a8

Version: 3

Effective Time: 20220426