ECOFREAKS HAND SANITIZER Peppermint

ECOFREAKS HAND SANITIZER by

Drug Labeling and Warnings

ECOFREAKS HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by Sanitizer Supply, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ECOFREAKS HAND SANITIZER- alcohol gel 
Sanitizer Supply, LLC

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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ECOFREAKS

HAND SANITIZER

Peppermint

Drug Facts

   Active ingredient                              Purpose

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

Purpose:  Antiseptic

Warnings

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

Uses

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

Do not use

• on 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.

Otherinformation

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

Inactive ingredients  water, poly acrylic acid, aloe vera leaf, hydrogen peroxide, Mentha Piperita (Peppermint) Oil

ECOFREAKS HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 90026-012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.8 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
POLYACRYLIC ACID (450000 MW) (UNII: KD3S7H73D3)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
PEPPERMINT OIL (UNII: AV092KU4JH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 90026-012-06	117 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/23/2020
2	NDC: 90026-012-12	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/23/2020
3	NDC: 90026-012-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/23/2020
4	NDC: 90026-012-01	2 mL in 1 PACKET; Type 0: Not a Combination Product	12/07/2020
5	NDC: 90026-012-03	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/07/2020
6	NDC: 90026-012-08	234 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/07/2020
7	NDC: 90026-012-90	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/07/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	11/23/2020	04/27/2022

Labeler - Sanitizer Supply, LLC (117594299)

Establishment
Name	Address	ID/FEI	Business Operations
Sanitizer Supply, LLC		117594299	manufacture(90026-012) , label(90026-012) , pack(90026-012)

Revised: 4/2022

Document Id: ddb9bd6b-c828-7d2d-e053-2995a90aa115

34390-5

Set id: 4d6b6e43-d24b-4ded-8157-2cb5a6fb4373

Version: 3

Effective Time: 20220428