Antibacterial Wipes by SJ Creations, Inc. / Tonic Bath & Body Products Shenzhen Ltd Drug Facts

Antibacterial Wipes by

Drug Labeling and Warnings

Antibacterial Wipes by is a Otc medication manufactured, distributed, or labeled by SJ Creations, Inc., Tonic Bath & Body Products Shenzhen Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ANTIBACTERIAL WIPES- benzalkonium chloride swab 
SJ Creations, 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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Drug Facts

Active Ingredient(s)

Benzalkonium Chloride 0.1% v/v. Purpose: Antiseptic

Purpose

Antibacterial, Wipe

Use

Hand sanitizer to help reduce bacteria on the skin.

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

• Wet hands thoroughlly with product and allow to dry
• Children under 6 years of age should be supervised with using this product.

Other information

• Store between 20-25C (68-77F)
• Avoid freezing and excessive heat above 40C (104F)
• May discolor some fabrics

Inactive ingredients

Water, Ethyl Alcohol, Glycerin, Propylene Glycol, Phenoxyethanol, Didecyldimethylammonium Chloride, Exylhexylglycerin.

Package Label - Principal Display Panel

60ct NDC: 43269-980-60

ANTIBACTERIAL WIPES 
benzalkonium chloride swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43269-980
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.1 mg  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43269-980-60	0.1 mL in 1 POUCH; Type 0: Not a Combination Product	07/16/2020	07/16/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/16/2020	07/16/2022

Labeler - SJ Creations, Inc. (146379495)

Establishment
Name	Address	ID/FEI	Business Operations
Tonic Bath & Body Products Shenzhen Ltd		528197042	manufacture(43269-980)

Revised: 9/2021

Document Id: cbe65f38-3c62-7b08-e053-2a95a90a60b4

34390-5

Set id: aa92ae80-b5cb-e6b3-e053-2a95a90aa51d

Version: 3

Effective Time: 20210913