99.99% DISINFECTION WIPES- 99.99% disinfection wipes cloth
QUANZHOU V-CARE SANITARY 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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80515-002
99.99% Disinfection wipes

Active Ingredient(s)

Benzalkonium chloride (0.13%)
Potassium sorbate(0.6%)
Chlorphenesin(0.37%)

Purpose

Use

Instruction for use

Warnings

When using this product
Caution:Please put it in a cootapd dry place, avoid direct sunlight, do not let children touch it

Do not use

Caution:Please put it in a cootapd dry place, avoid direct sunlight, do not let children touch it

Directions

Gently open the protective seal
Remove the wipes from the package and use it directly on the skin
Use the wipe to clean and avoid to use on sensitive areas, such as eyes and wounds
Once you have finished, close the package by pressing the protactive seal
Avoid to keep the protective seal uncovered

Other information

Inactive ingredients

Aqua(75%)

Package Label - Principal Display Panel

80515-002-06 80P 80515-002-05 60P 80515-002-02 20P 80515-002-04 50P 80515-002-07 100P 80515-002-03 40P 80515-002-01 10P

99.99% DISINFECTION WIPES
99.99% disinfection wipes cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:80515-002
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g in 100
POTASSIUM SORBATE (UNII: 1VPU26JZZ4) (SORBIC ACID - UNII:X045WJ989B)	POTASSIUM SORBATE	0.6 g in 100
CHLORPHENESIN (UNII: I670DAL4SZ) (CHLORPHENESIN - UNII:I670DAL4SZ)	CHLORPHENESIN	0.37 g in 100

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:80515-002-02	20 in 1 BAG; Type 0: Not a Combination Product	03/30/2020
2	NDC:80515-002-03	40 in 1 BAG; Type 0: Not a Combination Product	03/30/2020
3	NDC:80515-002-04	50 in 1 BAG; Type 0: Not a Combination Product	03/30/2020
4	NDC:80515-002-05	60 in 1 BAG; Type 0: Not a Combination Product	03/30/2020
5	NDC:80515-002-06	80 in 1 BAG; Type 0: Not a Combination Product	03/30/2020
6	NDC:80515-002-07	100 in 1 BAG; Type 0: Not a Combination Product	03/30/2020
7	NDC:80515-002-01	10 in 1 BAG; Type 0: Not a Combination Product	03/30/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	03/30/2020

Labeler - QUANZHOU V-CARE SANITARY PRODUCTS CO.,LTD (543052297)

Name	Address	ID/FEI	Business Operations
Establishment
QUANZHOU V-CARE SANITARY PRODUCTS CO.,LTD		543052297	manufacture(80515-002)

80515-002 99.99% Disinfection wipes