Sipa Antibacterial Wipes by Zhejiang Ruolin Hygienic Products Co., Ltd. Antibacterial Wipes

Sipa Antibacterial Wipes by

Drug Labeling and Warnings

Sipa Antibacterial Wipes by is a Otc medication manufactured, distributed, or labeled by Zhejiang Ruolin Hygienic Products Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SIPA ANTIBACTERIAL WIPES- benzalkonium chloride swab 
Zhejiang Ruolin Hygienic 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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Antibacterial Wipes

Active Ingredient

Benzalkonium Chloride 0.13%

Purpose

Antimicrobial

USE

Hand sanitizer to help reduce bacteria on the skin.

Warning

• For external use only.
• When using this product, Do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

• Stop use and ask a doctor, if irritaion and rash appears and lasts.

If swallowed, get medical help or contact a Poison Contrl Center right away.

Directions

• Wet hands thoroughly with product and allow to dry
• Discard wipes in trash receptacle after use. Do not flush.
• Children under 6 years of age should be supervised when using this product.

Inactive ingredients

Water, Glycerin, Ehtylhexylglycerin, Phenoxyethanol, Propylene Glycol, Decyl Glucoside, Aloe Barbadensis Leaf Extract

SIPA ANTIBACTERIAL WIPES 
benzalkonium chloride swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78823-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78823-003-01	100 in 1 CANISTER	06/25/2020	06/27/2020
1		2.82 g in 1 POUCH; 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	06/25/2020	06/27/2020

Labeler - Zhejiang Ruolin Hygienic Products Co., Ltd. (415426870)

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Ruolin Hygienic Products Co., Ltd.		415426870	manufacture(78823-003)

Revised: 6/2020

Document Id: 5d73190d-f93d-4f00-9684-6cc3f2c75403

34390-5

Set id: a18548a4-6a39-4b60-bd95-6fbf81510007

Version: 10

Effective Time: 20200627

 

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