Pure + Dew Antibacterial Hand Soap

Pure Dew by

Drug Labeling and Warnings

Pure Dew by is a Otc medication manufactured, distributed, or labeled by HOME & BODY COMPANY. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURE DEW- benzalkonium chloride liquid 
HOME & BODY COMPANY

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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Pure + Dew Antibacterial Hand Soap

Active ingredient

0.13% Benzalkonium Chloride

Purpose

Antibacterial

Use

Helps reduce bacterial on hands

Warning

For external use only.
When using this product do not use in or near the eyes.
In case of contact, rinse eyes throughly with water.

Keep out of reach of children

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

Directions

Wash hands and rinse

Inactive Ingredients

Water (Aqua), Lauramine Oxide, Cellulose Gum, Tetrasodium EDTA, Polysorbate 20, Fragrance, Glycerin, Cocamidopropyl Betaine

Product Label

PURE DEW 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73746-031
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
POLYSORBATE 20 (UNII: 7T1F30V5YH)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
EDETATE SODIUM (UNII: MP1J8420LU)
WATER (UNII: 059QF0KO0R)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73746-031-01	1893 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2020
2	NDC: 73746-031-02	473 mL in 1 BOTTLE, PLASTIC; 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	part333E	06/01/2020	10/05/2022

Labeler - HOME & BODY COMPANY (081290720)

Registrant - HOME & BODY COMPANY (081290720)

Establishment
Name	Address	ID/FEI	Business Operations
HOME & BODY COMPANY		081290720	manufacture(73746-031)

Revised: 10/2022

Document Id: ea614b18-c62e-fa11-e053-2a95a90a6279

34390-5

Set id: a70ce788-4bef-3e6d-e053-2995a90a2ee7

Version: 3

Effective Time: 20221006