ANTIBACTERIAL WIPES- hand sanitizer cloth 
FuYang YangYang Health Technology Co. Ltd

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active Ingredient(s)

Benzalkonium Chloride 0.13% w/w. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Decreases bacteria and germs on the skin that could cause disease.

Warnings

For external use only.

Do not use

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 and ask a doctor if

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Other information

Inactive ingredients

aloe barbadensis leaf juice, fragrance, phenoxyethanol, polysorbate 20, propylene glycol, tocopheryl acetate, water.

Package Label - Principal Display Panel

10 Wipes in 1 BAG NDC: 76641-011-04 Package Label

ANTIBACTERIAL WIPES 
hand sanitizer cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76641-011
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.3 g  in 100 g
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.2 g  in 100 g
ALOE (UNII: V5VD430YW9) 0.2 g  in 100 g
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK) 0.03 g  in 100 g
WATER (UNII: 059QF0KO0R) 97.94 g  in 100 g
POLYSORBATE 20 (UNII: 7T1F30V5YH) 0.2 g  in 100 g
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 1 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76641-011-0448.6 g in 1 BAG; Type 0: Not a Combination Product08/11/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/11/2020
Labeler - FuYang YangYang Health Technology Co. Ltd (529735460)
Registrant - FuYang YangYang Health Technology Co. Ltd (529735460)
Establishment
NameAddressID/FEIBusiness Operations
FuYang YangYang Health Technology Co. Ltd529735460manufacture(76641-011)

Revised: 8/2020
Document Id: ac826b40-1003-2fb3-e053-2a95a90a48b3
Set id: ac827719-e81b-621d-e053-2995a90a21ed
Version: 1
Effective Time: 20200811
 
FuYang YangYang Health Technology Co. Ltd