ATOREN ANTIBACTERIAL WIPES- alcohol liquid
MLS

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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73984-334

ACTIVE INGREDIENT

Ethyl Alcohol 75%

PURPOSE

Antiseptic

USE

Decreases bacteria on skin.

WARNINGS

For external use only. Flammable product. Keep away from heat or flame.

WARNINGS

Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

WARNINGS

Stop use and ask a doctor if irritation develops.

WARNINGS

Keep out of reach of children. If swallowed, call a poison control center or get medical help right away.

DIRECTIONS

Adults and children over 2 years old: For occasional and personal domestic use. Supervise children when they use this product. Rub thoroughly into hands for at least 30 seconds. Allow to dry.

OTHER INFORMATION

Store between 15-30C (59-86F). Avoid freezing and excessive heat above 40C (104F)

INACTIVE INGREDIENTS

Water, Citric Acid, Sodium Citrate, Butylene Glycol

DO NOT USE

if you are allergic to any of the ingredients.

PACKAGE LABEL

190g NDC: 73984-334-01 Label

ATOREN ANTIBACTERIAL WIPES
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73984-334
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:73984-334-01	190 g in 1 POUCH; Type 0: Not a Combination Product	07/08/2020	12/31/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	07/08/2020	12/31/2020

Labeler - MLS (689850283)

Registrant - MLS (689850283)

Name	Address	ID/FEI	Business Operations
Establishment
MLS		689850283	manufacture(73984-334)

Revised: 1/2021

Document Id: b937cf6a-0837-9136-e053-2a95a90ad07c

Set id: a9ed2712-dbe4-3deb-e053-2995a90a0ca3

Version: 2

Effective Time: 20210118

MLS