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 fire and flame

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

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

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 when using this product.

Other information

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

Inactive ingredients

Water (Aqua), Ethyl Alcohol, Glycerin, Propylene Glycol, Phenoxyethanol, Didecyldimethylammonium Chloride, Exylhexylglycerin, Citrus Medica Limonum (Lemon) Peel Oil Fragrance (Parfum).

Package Label - Principal Display Panel

60ct NDC: 43269-999-60

ANTIBACTERIAL WIPES 
benzalkonium chloride swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43269-999
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
LEMON OIL (UNII: I9GRO824LL)
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: 43269-999-60	0.1 mL in 1 POUCH; Type 0: Not a Combination Product	09/29/2020	09/29/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/29/2020	09/29/2022

Labeler - SJ Creations, Inc. (146379495)

Establishment
Name	Address	ID/FEI	Business Operations
Tonic Bath & Body Products Shenzhen Ltd		528197042	manufacture(43269-999)

Revised: 9/2021

Document Id: cbe67c80-195e-25c8-e053-2995a90a4b1e

34390-5

Set id: b07f0f1b-be04-7c86-e053-2a95a90a5148

Version: 3

Effective Time: 20210913