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Drug Labeling and Warnings

Premium Disinfecting Alcohol Wipes by is a Otc medication manufactured, distributed, or labeled by Xiamen Yiukin Paper Products Co.,ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PREMIUM DISINFECTING ALCOHOL WIPES- alcohol, benzalkonium chloride cloth 
Xiamen Yiukin Paper Products 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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Active Ingredient(s)

Alcohol 75%. Purpose: Antiseptic

Benzalkonium chloride 0.1%. Purpose: Antiseptic

Purpose

Antiseptic

Use

Kills 99.9% of bacteria

Disinfecting & Sterilizing Wipes

Helps Prevent Virus Transmission

Warnings

Supervise children under 6 years of age when using this product to avoid swallowing.

Keep out of reach of children.

Do not use on open skin wounds.

Keep out of eye, ears and mouth. In case of contact with eyes, rinse with water immediately and seek medical attention if necessary.

If you have an anaphylactic or any other allergic reaction, stop use and seek medical attention.

Do not use on open skin wounds.

Keep out of eye, ears and mouth. In case of contact with eyes, rinse with water immediately and seek medical attention if necessary.

If you have an anaphylactic or any other allergic reaction, stop use and seek medical attention.

Supervise children under 6 years of age when using this product to avoid swallowing.

Keep out of reach of children.

Directions

Open package lid and wipe skin until dry

Preserve at normal temperature between (15-30C / 59-86F)

Avoid freezing and excessive heat above 40C (104F)

Other information

Preserve at normal temperature between (15-30C / 59-86F)

Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

water/ Cetylpyridinium chloride /phenoxy ethanol/Propylene glycol

Package Label - Principal Display Panel

50 PC NDC: 79288-016-01

SAFECARE

INTERNATIONAL

Safe Formula

Over 99.9%

Flexible & Strong

50

Net Content

Wipes 6 x 8 in

1.6 oz. (45g)

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DISINFECTING WIPES

Contains

75% ALCOHOL

Kills 99.9% of Bacteria

For Disinfecting & Sterilizing/Helps Prevent Virus Transmission

PREMIUM DISINFECTING ALCOHOL WIPES 
alcohol, benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79288-016
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.1 g  in 100 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79288-016-01	50 in 1 BAG	09/18/2020	05/01/2022
1		7 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/18/2020	05/01/2022

Labeler - Xiamen Yiukin Paper Products Co.,ltd (526049172)

Establishment
Name	Address	ID/FEI	Business Operations
Xiamen Yiukin Paper Products Co.,ltd		526049172	manufacture(79288-016) , label(79288-016)

Revised: 5/2022

Document Id: ddee9ab7-7f18-bd09-e053-2995a90a8358

34390-5

Set id: af9b103b-ad66-b12b-e053-2995a90a92bf

Version: 3

Effective Time: 20220501