HAND SANITIZING WIPES- alcohol cloth

Hand Sanitizing Wipes by

Drug Labeling and Warnings

Hand Sanitizing Wipes by is a Otc medication manufactured, distributed, or labeled by SUMEC Hardware & Tools Co., Ltd., A03 Lab of BTS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Ethyl alcohol 80% v/v. Purpose: Antiseptic

Purpose

Antiseptic

Use

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

Warnings

Flammable. Keep away from heat or flame. For external use only. Not for use as a baby wipe.

Do not use

• on children less than 2 months of age
• on damaged or sensitive skin

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

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.

Directions

• Remove wipe from package. Reseal package to prevent wipes from drying out. Then apply wipe to hands and clean thoroughly.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

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

Inactive ingredients

Glycerol, Aloe extract, Sodium Hyaluronate, Trolamine, Water (aqua), Denatonium

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

HAND SANITIZING WIPES 
alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74035-2051
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	4.5 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
DENATONIUM BENZOATE ANHYDROUS (UNII: M5BA6GAF1O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74035-2051-2	4 in 1 CARTON	09/03/2020
1	NDC: 74035-2051-1	50 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/03/2020

Labeler - SUMEC Hardware & Tools Co., Ltd. (654687771)

Registrant - A03 Lab of BTS (548009541)

Establishment
Name	Address	ID/FEI	Business Operations
SUMEC Hardware & Tools Co., Ltd.		654687771	manufacture(74035-2051) , label(74035-2051)