75% alcohol wipes by Baoding Yusen Sanitary Health Supplies Co.,Ltd

75% alcohol wipes by

Drug Labeling and Warnings

75% alcohol wipes by is a Otc medication manufactured, distributed, or labeled by Baoding Yusen Sanitary Health Supplies Co.,Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

75% ALCOHOL WIPES- alcohol cloth 
Baoding Yusen Sanitary Health Supplies 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.

----------

Drug Facts

Active Ingredient(s)

Ethanol 75% v/v

Purpose

Antiseptic

Use

For hand sanitizing to decrease bacterial on skin.

Warnings

For external use only.Keep away from fire or flame.

Do not use

Do not use In children less than 2 months of age. On open skin wounds.

When using this product avoid contact with eyes and mouth. If in eyes, flush thoroughly with water.

Discontinue use and contact a doctor if irritation and redness develop and conditions persist for more than 72 hours.

Keep out of reach of children unless under adult supervision. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Tear open packet and remove wipe. Throw used wipe in trash. Do not flush.

Other information

Shelf Life: 24 months

Inactive ingredients

Water.

Package Label - Principal Display Panel

75% ALCOHOL WIPES 
alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78508-001
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 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78508-001-01	198 mL in 1 BAG; Type 0: Not a Combination Product	06/02/2020	01/07/2021
2	NDC: 78508-001-02	5.148 mL in 1 BAG; Type 0: Not a Combination Product	06/11/2020	01/07/2021
3	NDC: 78508-001-03	57.75 mL in 1 BAG; Type 0: Not a Combination Product	07/27/2020	01/07/2021
4	NDC: 78508-001-04	288.75 mL in 1 BAG; Type 0: Not a Combination Product	07/27/2020	01/07/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/02/2020	01/07/2021

Labeler - Baoding Yusen Sanitary Health Supplies Co.,Ltd (530919462)

Registrant - Baoding Yusen Sanitary Health Supplies Co.,Ltd (530919462)

Establishment
Name	Address	ID/FEI	Business Operations
Baoding Yusen Sanitary Health Supplies Co.,Ltd		530919462	manufacture(78508-001)

Revised: 1/2021

Document Id: b8463412-d6eb-19a0-e053-2995a90a5c1b

34390-5

Set id: a70fc463-ee5f-6fd2-e053-2a95a90a51a4

Version: 4

Effective Time: 20210106

 

Baodin