SANITIZING ALCOHOL FREE WIPES cloth

Sanitizing Alcohol Free Wipes by

Drug Labeling and Warnings

Sanitizing Alcohol Free Wipes by is a Otc medication manufactured, distributed, or labeled by Shedrain Corporation, Zhangzhou Zhongnan Nursing Products Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Active ingredient for this sanitizing alcohol-free wipes is Benzalkonium chloride

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Purpose

Hand Sanitizer to help decrease bacteria on the skin.

Use

For dispensing: Peel back front label at tab. Remove towelette wipes as needed. Reseal pouch by pressing label firmly back into place.

For use: Apply thoroughly to hands as desired. Allow to dry without wiping. Discard wipe in trash after use. Do not flush.

Warnings

For external use only.

Do not use

Do not use in or near the eyes. If contact occurs, flush thoroughly with water.

STOP USE

Stop use and contact doctor if redness and irritation develops and persists.

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.

Inactive ingredients

Aqua (Water), Polyaminopropyl Biguanide, Xylitol Extract, Aloe Barbadensis Leaf Extract.

Dosage

FOR DISPENSING: Peel back front label at tab. Remove towelette wipes as needed.

FOR USE: Apply thoroughly to hands asdesired. Allow to dry without wiping.

Package Label - Principal Display Panel

20-pack. NDC: 80380-100-01

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INGREDIENTS AND APPEARANCE

SANITIZING ALCOHOL FREE WIPES 
sanitizing alcohol free wipes cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80380-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET)	0.5 mg  in 100 mg
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.04 mg  in 100 mg
WATER (UNII: 059QF0KO0R)	99.3 mg  in 100 mg
XYLITOL (UNII: VCQ006KQ1E)	0.03 mg  in 100 mg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80380-100-01	20 mg in 1 PACKET; Type 0: Not a Combination Product	10/23/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/23/2020

Labeler - Shedrain Corporation (009025552)

Establishment
Name	Address	ID/FEI	Business Operations
Zhangzhou Zhongnan Nursing Products Co., Ltd		416376835	manufacture(80380-100)