Modere by Maple Mountain Group, Inc.

Modere by

Drug Labeling and Warnings

Modere by is a Otc medication manufactured, distributed, or labeled by Maple Mountain Group, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MODERE- hand sanitizer lotion 
Maple Mountain Group, Inc.

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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Drug Facts

Active Ingredient

Alcohol 80% v/v

Purpose

Alcohol 80% v/v..........Antiseptic

Uses

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For External use only. Flammable. Keep away from heat or flame.

Do not use

• in children less than 2 months of age
• on open skin wounds

When using this product keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.

Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information

Store between 1-30C (59-86F)

Avoid freezing and excessive heat above 40C (104F).

Inactive Ingredients

glycerin, hydrogen peroxide, purified water USP

Distriuted by Modere, Inc

588 S. 2000 W. Springville, Utah 84663

Learn more at modere.com

Made in USA. Ingredients from USA and/or imported.

Modere

alcohol antiseptic 80%

topical solution

hand sanitizer

cleanse

non-sterile solution

120mL / 4 FL OZ

MODERE 
hand sanitizer lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79400-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	96 mL  in 120 mL

Inactive Ingredients
Ingredient Name	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79400-100-01	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/06/2020	12/31/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/06/2020	12/31/2022

Labeler - Maple Mountain Group, Inc. (161820212)

Establishment
Name	Address	ID/FEI	Business Operations
Maple Mountain Group, Inc.		161820212	label(79400-100)

Establishment
Name	Address	ID/FEI	Business Operations
Maple Mountain Group, Inc.		965790285	manufacture(79400-100)

Revised: 12/2022

Document Id: f0ff9253-2a1c-7e7e-e053-2995a90a55b5

34390-5

Set id: a9c72936-c571-060b-e053-2995a90a6125

Version: 2

Effective Time: 20221229