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

Benzalkonium Chloride 0.1% v/v

Purpose

Antibacterial, Wipe

Use

Hand sanitizer to help reduce bacteria on the skin.

Warnings

For external use only.

Flammable.

Keep away from fire and flame.

When using this product

When using this product avoid contact with eyes. In case of contact, rince eyes thoroughly with water.

Stop use and ask a doctor

Stop use and ask a doctor if irritation and redness develop.

Keep out of Reach of Children

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

Directions

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

Other information

• Store between 20C to 25C (68F to 77F)
• May discolor some fabrics or surfaces

Inactive Ingredients

Water(Aqua), Ethyl Alcohol, Glycerin, Propylene Glycol, Lavender Oil, Phenoxyethanol, Didecyldimethylammonium Chloride, Exylhexylglycerin, Fragrance (Parfum).

Package Label - Principal Display Panel

60ct NDC: 43269-985-60

ANTIBACTERIAL WIPES 
benzalkonium chloride swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43269-985
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
ALCOHOL (UNII: 3K9958V90M)
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)
WATER (UNII: 059QF0KO0R)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
LAVENDER OIL (UNII: ZBP1YXW0H8)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43269-985-60	0.1 mL in 1 POUCH; Type 0: Not a Combination Product	09/02/2020	09/20/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/02/2020	09/20/2022

Labeler - SJ Creations, Inc. (146379495)

Registrant - Tonic Bath & Body Products Shenzhen Ltd (528197042)

Establishment
Name	Address	ID/FEI	Business Operations
Tonic Bath & Body Products Shenzhen Ltd		528197042	manufacture(43269-985)

Revised: 9/2021

Document Id: cbe66131-331c-0abf-e053-2a95a90a86f0

34390-5

Set id: ae4e9fa0-40ab-b71c-e053-2995a90a0ff2

Version: 4

Effective Time: 20210913