ALCOHOL WET WIPES- alcohol cloth

Alcohol Wet Wipes by

Drug Labeling and Warnings

Alcohol Wet Wipes by is a Otc medication manufactured, distributed, or labeled by Fujian Mengjiaolan Daily Chemical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

The 75% ALCOHOL TOWEL 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:

Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (75%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
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

Alcohol 75% v/v. Purpose: Antiseptic

PURPOSE

Antiseptic

INDICATIONS & USAGE

75% ALCOHOL TOWEL 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

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

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.

DOSAGE & ADMINISTRATION

Wipe hands, face, skin, etc.
Supervise children under 6 years of age when using this product to avoid swallowing.

STORAGE AND HANDLING

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

INACTIVE INGREDIENT

water

PRINCIPAL DISPLAY PANEL

48 CLOTH in 1 PACKAGE NDC: 74531-001-01

INGREDIENTS AND APPEARANCE

ALCOHOL WET WIPES 
alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74531-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.75 mL  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74531-001-01	75 mL in 1 PACKAGE; Type 0: Not a Combination Product	03/30/2020

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

Labeler - Fujian Mengjiaolan Daily Chemical Co., Ltd. (546632451)

Establishment
Name	Address	ID/FEI	Business Operations
Fujian Mengjiaolan Daily Chemical Co., Ltd.		546632451	manufacture(74531-001)