SANI WIPES by Xiamen Yiukin Paper Products Co.,ltd SANI WIPES

SANI WIPES by

Drug Labeling and Warnings

SANI 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]

SANI 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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SANI WIPES

Active Ingredient(s)

Alcohol 12%. Purpose: Antiseptic

Benzalkonium chloride 0.1%. Purpose: Antiseptic

Purpose

Antiseptic

Use

For hand washng to decrease bacteria on the skin

Warnings

For external use only.

Keep out of reach of eyes. If contact occurs, rinse thoroughly with water.

Do not use if you are allergic to any of the ingredients.

Discontinue use if irritation or redness develops, and if condition persists for more than 72 hours consult a physician.

Keep out of reach of children unless under adult supervision.

If swallowed, get medical help, or contact a Poison Control Center immediately.

Do not use if you are allergic to any of the ingredients.

Keep out of reach of eyes. If contact occurs, rinse thoroughly with water.

Discontinue use if irritation or redness develops, and if condition persists for more than 72 hours consult a physician.

Keep out of reach of children unless under adult supervision.

If swallowed, get medical help, or contact a Poison Control Center immediately.

Directions

Open resealable label and pull one sheet from pack. Thoroughly clean hands or affected area and discard in receptable. Be sure to reseal label complete to retain moisture.

Do not flush after using. Please throw the wipe in the trash.

Other information

Store at room temperature.

Avoid sunlight irradiating.

Inactive ingredients

Water / Cetylpyridinium chloride / Chlorphenesin / Biguanide / Propylene glycol

Package Label - Principal Display Panel

80 PC NDC: 79288-011-01

AIRE

SANI WIPES

CONTAINS 75% ALCOHOL

The company passed the ISO9001-2015 quality management system certification.

The company paseed the ISO14001-2015 environmental management system certification.

80 PCS

Soft touch and strong shrinkage

Eliminae cross infection

SANI WIPES 
alcohol, benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79288-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	12 mL  in 100 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
BIGUANIDE (UNII: FB4Q52I9K2)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
CHLORPHENESIN (UNII: I670DAL4SZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79288-011-01	80 in 1 BAG	08/10/2020	05/01/2022
1		5.8 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	08/10/2020	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(79288-011) , label(79288-011)

Revised: 5/2022

Document Id: ddee819e-1e6e-2ebe-e053-2a95a90a66cd

34390-5

Set id: ac8e6c78-e7f8-f3aa-e053-2a95a90a1531

Version: 3

Effective Time: 20220501