SANITIZER WIPES- benzalkonium chloride solution

Sanitizer Wipes by

Drug Labeling and Warnings

Sanitizer Wipes by is a Otc medication manufactured, distributed, or labeled by AMSAT International, Inc., Hangzhou Caring Cleaning Commodity Co., Ltd, Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

BENZALKONIUM CHLORIDE 0.1%

Purpose

Purpose: Antimicrobial

Use

Hand Sanitizer to help reduce bacteria on the skin

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

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

• Wet hands thoroughly with product and allow to dry.
• Discard wipes in trash receptacle after use. Do not flush
• Children under 6 years of age should be supervised when using this product.

Inactive ingredients

Ethylhexylglycerin, Glycerin, Phenoxyethanol, Polyaminopropyl biguanide, Propylene Glycol, Purified water

Package Label - Principal Display Panel

10 mL NDC: 79438-002-10

75 mL NDC: 79438-002-75

50 mL NDC: 79438-002-50

INGREDIENTS AND APPEARANCE

SANITIZER WIPES 
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79438-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.1 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79438-002-10	10 mg in 1 PACKET; Type 0: Not a Combination Product	07/23/2020
2	NDC: 79438-002-75	75 mg in 1 PACKET; Type 0: Not a Combination Product	07/23/2020
3	NDC: 79438-002-50	50 mg in 1 PACKET; Type 0: Not a Combination Product	07/23/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/23/2020

Labeler - AMSAT International, Inc. (806393943)

Establishment
Name	Address	ID/FEI	Business Operations
Hangzhou Caring Cleaning Commodity Co., Ltd		413905445	manufacture(79438-002)

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd.		723796509	manufacture(79438-002)

Establishment
Name	Address	ID/FEI	Business Operations
AMSAT International, Inc.		806393943	manufacture(79438-002)