INSTANT HAND SANITIZEING WIPE- benzalkonium chloride cloth

Instant Hand Sanitizeing Wipe by

Drug Labeling and Warnings

Instant Hand Sanitizeing Wipe 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

Instant Hand Sanitizeing Wipe

Active Ingredient(s)

Benzalkonium Chloride 0.05% w/w. Purpose: Antiseptic

Purpose

Antiseptic

Use

Instant Hand Sanitizeing Wipe to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only.

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

Propylene Glycol
Aqua
Phenoxyethanol
Glycerin
Aloe Barbadensis leaf Extractt
Disodium EDTA
Getylpyridinium Chloride
Sodium Citrate
TocopherylAcetate
Tea tree oil
Perfum

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

INSTANT HAND SANITIZEING WIPE 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79539-601
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.05 mg  in 100

Inactive Ingredients
Ingredient Name	Strength
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
CHLORIDE ION (UNII: Q32ZN48698)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
CANANGA ODORATA LEAF OIL (UNII: 6W864D0X3X)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
TEA TREE OIL (UNII: VIF565UC2G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79539-601-01	1 in 1 BAG; Type 0: Not a Combination Product	11/21/2020
2	NDC: 79539-601-02	10 in 1 BAG; Type 0: Not a Combination Product	11/21/2020
3	NDC: 79539-601-03	20 in 1 BAG; Type 0: Not a Combination Product	11/21/2020
4	NDC: 79539-601-04	25 in 1 BAG; Type 0: Not a Combination Product	11/21/2020
5	NDC: 79539-601-05	30 in 1 BAG; Type 0: Not a Combination Product	11/21/2020
6	NDC: 79539-601-06	40 in 1 BAG; Type 0: Not a Combination Product	11/21/2020
7	NDC: 79539-601-07	50 in 1 BAG; Type 0: Not a Combination Product	11/21/2020
8	NDC: 79539-601-08	60 in 1 BAG; Type 0: Not a Combination Product	11/21/2020
9	NDC: 79539-601-09	64 in 1 BAG; Type 0: Not a Combination Product	11/21/2020
10	NDC: 79539-601-10	70 in 1 BAG; Type 0: Not a Combination Product	11/21/2020
11	NDC: 79539-601-11	72 in 1 BAG; Type 0: Not a Combination Product	11/21/2020
12	NDC: 79539-601-12	80 in 1 BAG; Type 0: Not a Combination Product	11/21/2020
13	NDC: 79539-601-13	100 in 1 BAG; Type 0: Not a Combination Product	11/21/2020
14	NDC: 79539-601-14	120 in 1 BAG; Type 0: Not a Combination Product	11/21/2020
15	NDC: 79539-601-15	150 in 1 BAG; Type 0: Not a Combination Product	11/21/2020
16	NDC: 79539-601-16	160 in 1 BAG; Type 0: Not a Combination Product	11/21/2020
17	NDC: 79539-601-17	180 in 1 BAG; Type 0: Not a Combination Product	11/21/2020
18	NDC: 79539-601-18	200 in 1 BAG; Type 0: Not a Combination Product	11/21/2020
19	NDC: 79539-601-19	300 in 1 BAG; Type 0: Not a Combination Product	11/21/2020
20	NDC: 79539-601-20	400 in 1 BAG; Type 0: Not a Combination Product	11/21/2020
21	NDC: 79539-601-21	500 in 1 BAG; Type 0: Not a Combination Product	11/21/2020
22	NDC: 79539-601-22	600 in 1 BAG; Type 0: Not a Combination Product	11/21/2020
23	NDC: 79539-601-23	700 in 1 BAG; Type 0: Not a Combination Product	11/21/2020
24	NDC: 79539-601-24	800 in 1 BAG; Type 0: Not a Combination Product	11/21/2020
25	NDC: 79539-601-25	1000 in 1 BAG; Type 0: Not a Combination Product	11/21/2020
26	NDC: 79539-601-26	1200 in 1 BAG; Type 0: Not a Combination Product	11/21/2020
27	NDC: 79539-601-27	1600 in 1 BAG; Type 0: Not a Combination Product	11/21/2020
28	NDC: 79539-601-28	2000 in 1 BAG; Type 0: Not a Combination Product	11/21/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	11/21/2020

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

Establishment
Name	Address	ID/FEI	Business Operations
Shandong Yayun Sanitary Products Co., Ltd.		419983491	manufacture(79539-601)