waxman kleen hand sanitizing wipes 80765-008

WAXMAN KLEEN HAND SANITIZING WIPES by

Drug Labeling and Warnings

WAXMAN KLEEN HAND SANITIZING WIPES by is a Otc medication manufactured, distributed, or labeled by WAXMAN CONSUMER PRODUCTS GROUP INC., Zhejiang Ruolin Hygienic Products Co., Ltd., Guangzhou Daieme Cosmetic Cosmetic Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WAXMAN KLEEN HAND SANITIZING WIPES- benzalkonium chloride cloth 
WAXMAN CONSUMER PRODUCTS GROUP 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.

----------

waxman kleen hand sanitizing wipes 80765-008

Active Ingredients

Benzalkonium Chloride 0.1%

Purpose

Antibacterial

Use

Hand sanitizer to help reduce bacteria on the skin.

Warnings

For external use only.

When using this product do not use in or near the eyes.

In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash appears and lasts.

Keep out of reach of children.

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

Directions

• Wet hands thoroughly with product and allow to dry.
• Discard wipes in trash receptacle after use. Do not flush.
• Children under 6 years of age should be supervised when using this product.

Inactive Ingredient

Water, Alcohol, Glycerin, Ethylhexylglycerin, Phenoxyethanol, Didecyldimethylammonium Chloride, Propylene Glycol, Fragrance

Kills

99.9%

of Germs*

waxman

kleen

hand sanitizing wipes

LEMON SCENT

clean and sanitize hands

in one step

70 sheets 5.51 in x 7.87 in (14.0 cm x 20.0 cm)

WAXMAN KLEEN HAND SANITIZING WIPES 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80765-008
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80765-008-70	265 mL in 1 CANISTER; Type 0: Not a Combination Product	03/02/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/02/2021	12/31/2021

Labeler - WAXMAN CONSUMER PRODUCTS GROUP INC. (877456673)

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Ruolin Hygienic Products Co., Ltd.		415426870	manufacture(80765-008)

Revised: 7/2022

Document Id: e4f4ff93-469f-3aaa-e053-2995a90a0fc0

34390-5

Set id: bc909b19-4c82-fff0-e053-2995a90a2181

Version: 2

Effective Time: 20220729