ENVIROSOLUTIONS SANITIZING WIPES- isopropyl alcohol cloth

ENVIROSolutions Sanitizing Wipes by

Drug Labeling and Warnings

ENVIROSolutions Sanitizing Wipes by is a Otc medication manufactured, distributed, or labeled by Charlotte Products Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

1. Isopropyl Alcohol (75%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
2. Glycerol (1.45% v/v).
3. Hydrogen peroxide (0.125% v/v).
4. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

Isopropyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Personal hand sanitizing wipe to help reduce bacteria that potentially can cause disease.

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

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

Open the plastic tab at the front of the bottle. Pull up wipe and replace plastic cap. Always snap lid securely shut between uses to prevent moisture loss.

Take one wipe and rub onto hands to cover all surfaces. Let hands air dry.

NOT intended for intimate hygiene. Dispose of used wipes in trash.

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

STOP USE

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

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

Storage

Store at room temperature in a cool, dry place, avoid direct sunlight. Store below 110°F (43°C). Do not reuse empty canister.

Inactive ingredients

purified water

Package Label - Principal Display Panel

70 Count NDC: 64646-400-01

180 Count NDC: 64646-400-02

INGREDIENTS AND APPEARANCE

ENVIROSOLUTIONS SANITIZING WIPES 
isopropyl alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64646-400
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	70 mL  in 100 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64646-400-01	343 mL in 1 CANISTER; Type 0: Not a Combination Product	02/01/2021
2	NDC: 64646-400-02	1000 mL in 1 CANISTER; Type 0: Not a Combination Product	02/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	02/01/2021

Labeler - Charlotte Products Ltd. (248293359)

Registrant - Charlotte Products Ltd. (248293359)

Establishment
Name	Address	ID/FEI	Business Operations
Charlotte Products Ltd.		248293359	manufacture(64646-400)