Alcohol Wet Wipes: Package Insert and Label Information

ALCOHOL WET WIPES- alcohol cloth
Fujian Mengjiaolan Daily Chemical Co., Ltd.

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.

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.

Alcohol 75% v/v. Purpose: Antiseptic

Antiseptic

75% ALCOHOL TOWEL to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

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

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.

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

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

water

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

48pcs48pcs
ALCOHOL WET WIPES
alcohol cloth
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:74531-001
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 0.75 mL in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:74531-001-01 75 mL in 1 PACKAGE None
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 Operations
Fujian Mengjiaolan Daily Chemical Co., Ltd. 546632451 manufacture (74531-001)

Revised: 03/2020 Fujian Mengjiaolan Daily Chemical Co., Ltd.

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