73400-004 Antibacterial Wet wipes

Antibacterial Wet wipes by

Drug Labeling and Warnings

Antibacterial Wet wipes by is a Otc medication manufactured, distributed, or labeled by Xiamen Safercare Toiletries Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ANTIBACTERIAL WET WIPES- antibacterial wet wipes cloth 
Xiamen Safercare Toiletries Co., Ltd

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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73400-004
Antibacterial Wet wipes

Active ingredient

BENZALKONIUM CHLORIDE 0.3%

Purpose

Antiseptic

Diretions USE

Sanitizing Hand Wipes To Help Decrease Bacteria On The Skin.Recommended For Single Use.

WARNINGS SECTION

Do not freeze. Store at room temperature.
Do not use in ears, eyes or mouth.
Avoid contact with the eyes. In case of contact, flush eyes with water.

Stop use and ask a doctor if redness or irritation develop and persist for more than 72 hours.

Keep out of reach of children.

Do not use as a diaper wipe or sensitive skin.
Do not dispose used wipe down the toilet.

Keep away from heat and flame.
Call a Poison Control Centre or doctor for treatment advice.

Do not use as a diaper wipe or sensitive skin.
Do not dispose used wipe down the toilet.

Do not freeze. Store at room temperature.
Do not use in ears, eyes or mouth.

When using this product

Stop use and ask a doctor if redness or irritation develop and persist for more than 72 hours.

Keep out of reach of children.

Do not use as a diaper wipe or sensitive skin.
Do not dispose used wipe down the toilet.

Keep away from heat and flame.
Call a Poison Control Centre or doctor for treatment advice.

Stop use and ask a doctor if

Stop use and ask a doctor if redness or irritation develop and persist for more than 72 hours.

Keep out of reach of children

Keep out of reach of children.

Do not use as a diaper wipe or sensitive skin.
Do not dispose used wipe down the toilet.

Directions

Remove cover. Pull up wipe corner from center of roll. Thread through hole in the cover. Replace cover. Open center cap on cover to remove wipe. When not using, close center cap securely to prevent moisture loss.

Inactive Ingredients

Cetylpyidinium Chloride, Phenoxyethanol, Polyaminopropyl Biguanide,Propylene Glycol, Water(Aqua).

Oher information

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ANTIBACTERIAL WET WIPES 
antibacterial wet wipes cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73400-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.3 g  in 100

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73400-004-01	60 in 1 BOTTLE; Type 0: Not a Combination Product	03/18/2020
2	NDC: 73400-004-02	80 in 1 BOTTLE; Type 0: Not a Combination Product	03/18/2020
3	NDC: 73400-004-03	100 in 1 BOTTLE; Type 0: Not a Combination Product	03/18/2020
4	NDC: 73400-004-04	120 in 1 BOTTLE; Type 0: Not a Combination Product	03/18/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/18/2020	04/25/2021

Labeler - Xiamen Safercare Toiletries Co., Ltd (543006073)

Registrant - Xiamen Safercare Toiletries Co., Ltd (543006073)

Establishment
Name	Address	ID/FEI	Business Operations
Xiamen Safercare Toiletries Co., Ltd		543006073	manufacture(73400-004)

Revised: 4/2021

Document Id: c0c6f1ad-8835-46d1-e053-2995a90a56ae

34390-5

Set id: aff2efb9-fd98-45d1-e053-2a95a90a689d

Version: 2

Effective Time: 20210425