DE-LISTING 78880-615-10 Just 1 | 10 WIPES IN 1 PACKET | 78880-615-10 | HAND SANITIZING WIPES

Just 1 by

Drug Labeling and Warnings

Just 1 by is a Otc medication manufactured, distributed, or labeled by Sauber Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

JUST 1- alcohol cloth 
Sauber 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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DE-LISTING 78880-615-10 Just 1 | 10 WIPES IN 1 PACKET | 78880-615-10 | HAND SANITIZING WIPES

JUST 1 
alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78880-615
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.6152

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78880-615-10	10 in 1 PACKET; Type 0: Not a Combination Product	11/03/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	11/03/2020	01/07/2021

Labeler - Sauber Co.,Ltd. (690395844)

Establishment
Name	Address	ID/FEI	Business Operations
Sauber Co.,Ltd.		690395844	manufacture(78880-615)

Revised: 1/2021

Document Id: b85d7cd5-2831-57fb-e053-2a95a90a7605

34390-5

Set id: b32f75c1-1ea1-112b-e053-2995a90ae0c7

Version: 2

Effective Time: 20210108