ALCOHOL FORMULA SANITIZING HAND WIPES- alcohol and glycerol cloth

Alcohol Formula Sanitizing Hand Wipes by

Drug Labeling and Warnings

Alcohol Formula Sanitizing Hand Wipes by is a Otc medication manufactured, distributed, or labeled by Shandong Yayun Sanitary Products Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Alcohol Formula Sanitizing Hand Wipes

Active Ingredient(s)

Alcohol 1mL/pcs. Purpose: Antiseptic

Purpose

Antiseptic, Alcohol Formula Sanitizing Hand Wipes

Use

Alcohol Formula Sanitizing Hand Wipes 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.

Directions

• Wipe the surface of the skin and let it dry naturally.
• 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

WATER
Compound double-stranded quaternary ammonium salt
GLYCEROL

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

ALCOHOL FORMULA SANITIZING HAND WIPES 
alcohol and glycerol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79539-101
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79539-101-01	10 in 1 BAG; Type 0: Not a Combination Product	03/30/2020
2	NDC: 79539-101-02	20 in 1 BAG; Type 0: Not a Combination Product	03/30/2020
3	NDC: 79539-101-03	30 in 1 BAG; Type 0: Not a Combination Product	03/30/2020
4	NDC: 79539-101-04	40 in 1 BAG; Type 0: Not a Combination Product	03/30/2020
5	NDC: 79539-101-05	50 in 1 BAG; Type 0: Not a Combination Product	03/30/2020
6	NDC: 79539-101-06	60 in 1 BAG; Type 0: Not a Combination Product	03/30/2020
7	NDC: 79539-101-07	70 in 1 BAG; Type 0: Not a Combination Product	03/30/2020
8	NDC: 79539-101-08	80 in 1 BAG; Type 0: Not a Combination Product	03/30/2020
9	NDC: 79539-101-09	100 in 1 BAG; Type 0: Not a Combination Product	03/30/2020
10	NDC: 79539-101-10	120 in 1 BAG; Type 0: Not a Combination Product	03/30/2020
11	NDC: 79539-101-11	150 in 1 BAG; Type 0: Not a Combination Product	03/30/2020
12	NDC: 79539-101-12	160 in 1 BAG; Type 0: Not a Combination Product	03/30/2020
13	NDC: 79539-101-13	180 in 1 BAG; Type 0: Not a Combination Product	03/30/2020
14	NDC: 79539-101-14	200 in 1 BAG; Type 0: Not a Combination Product	03/30/2020
15	NDC: 79539-101-15	300 in 1 BAG; Type 0: Not a Combination Product	03/30/2020
16	NDC: 79539-101-16	400 in 1 BAG; Type 0: Not a Combination Product	03/30/2020
17	NDC: 79539-101-17	500 in 1 BAG; Type 0: Not a Combination Product	03/30/2020
18	NDC: 79539-101-18	600 in 1 BAG; Type 0: Not a Combination Product	03/30/2020
19	NDC: 79539-101-19	700 in 1 BAG; Type 0: Not a Combination Product	03/30/2020
20	NDC: 79539-101-20	800 in 1 BAG; Type 0: Not a Combination Product	03/30/2020
21	NDC: 79539-101-21	1000 in 1 BAG; Type 0: Not a Combination Product	03/30/2020
22	NDC: 79539-101-22	1200 in 1 BAG; Type 0: Not a Combination Product	03/30/2020
23	NDC: 79539-101-23	1600 in 1 BAG; Type 0: Not a Combination Product	03/30/2020
24	NDC: 79539-101-24	2000 in 1 BAG; 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 Drug	M003	03/30/2020

Labeler - Shandong Yayun Sanitary Products Co., Ltd. (419983491)

Establishment
Name	Address	ID/FEI	Business Operations
Shandong Yayun Sanitary Products Co., Ltd.		419983491	manufacture(79539-101)