Clean N Fresh 01 by SMC Technologies

Clean N Fresh 01 by

Drug Labeling and Warnings

Clean N Fresh 01 by is a Otc medication manufactured, distributed, or labeled by SMC Technologies. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CLEAN N FRESH 01- hand sanitizer gel 
SMC Technologies

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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Ingredients

This hand sanitizer is manufactured using the following ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

1. Alcohol (ethanol) (70%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
2. Carbomer Interpolymer Type A 55000 CPS
3. Water.
4. Trolamine
5. Fragrance.

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

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.

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

Inactive ingredients

Methacrylic Acid - Ethylacrylate Copolymer, Water, Trolamine, Fragrance

Package Label - Principal Display Panel

CLEAN N FRESH 01 
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77411-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	67.38 kg  in 100 kg

Inactive Ingredients
Ingredient Name	Strength
POLYSORBATE 20 (UNII: 7T1F30V5YH)	0.704 kg  in 100 kg
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)	0.618 kg  in 100 kg
TROLAMINE (UNII: 9O3K93S3TK)	0.286 kg  in 100 kg
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	white (Clear)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77411-004-55	185.45 kg in 1 DRUM; Type 0: Not a Combination Product	03/30/2020	12/31/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020	12/31/2022

Labeler - SMC Technologies (007188360)

Registrant - SMC Technologies (007188360)

Establishment
Name	Address	ID/FEI	Business Operations
SMC Technologies		007188360	manufacture(77411-004)

Revised: 9/2023

Document Id: 052cd263-a854-11a5-e063-6394a90a6698

34390-5

Set id: a950d453-80c9-b8ec-e053-2a95a90aa396

Version: 5

Effective Time: 20230912