HAND SANITIZING WIPES- hand sanitizing wipes patch
ZheJiang HuaShun 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%. Purpose: Antiseptic

Purpose

Antiseptic

USES

For sanitizing to decrease bacteria on skin

apply topically to the skin to help prevent cross contamination

recommended for repeated use

dries in seconds

Warnings

For external use only.

May irritate eyes

Keep out of reach of children unless under adult supervision

Inactive ingredients

Water, Propylene Glycol,Disodium EDTA,Chloro-methyl-isothiazolinone and Methyl-isothiazolinone,Potassium Sorbate,Quatermium-15,Aloe Barbadensis Leaf Juice,Disodium Cocoamphodiacetate,Vitamin E Acetate,Polysorbate-20,Citric Acid,Fragrance.

Package Label - Principal Display Panel

package label

HAND SANITIZING WIPES
hand sanitizing wipes patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:77046-100
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) (METHYLCHLOROISOTHIAZOLINONE - UNII:DEL7T5QRPN)	METHYLCHLOROISOTHIAZOLINONE	0.0009 g in 100 g
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) (METHYLISOTHIAZOLINONE - UNII:229D0E1QFA)	METHYLISOTHIAZOLINONE	0.0003 g in 100 g
BRONOPOL (UNII: 6PU1E16C9W) (BRONOPOL - UNII:6PU1E16C9W)	BRONOPOL	0.03 g in 100 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)	0.02 g in 100 g
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	0.5 g in 100 g
POLYSORBATE 20 (UNII: 7T1F30V5YH)	0.15 g in 100 g
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)	0.15 g in 100 g
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.2 g in 100 g
EDETATE DISODIUM (UNII: 7FLD91C86K)	0.05 g in 100 g
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	0.01 g in 100 g
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)	0.02 g in 100 g
WATER (UNII: 059QF0KO0R)	98.7 g in 100 g

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:77046-100-02	1 in 1 PACKAGE	09/21/2020	09/28/2020
1		4 g in 1 PATCH; Type 0: Not a Combination Product
2	NDC:77046-100-01	30 in 1 PACKAGE	09/21/2020	09/28/2020
2		4 g in 1 PATCH; Type 0: Not a Combination Product
3	NDC:77046-100-03	100 in 1 BOX	09/28/2020
3		4 g in 1 PATCH; Type 0: Not a Combination Product
4	NDC:77046-100-04	3 in 1 BOX	09/28/2020
4		30 in 1 BAG
4		4.45 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	09/21/2020

Labeler - ZheJiang HuaShun Technology Co.,Ltd (527157837)

Name	Address	ID/FEI	Business Operations
Establishment
ZheJiang HuaShun Technology Co.,Ltd		527157837	manufacture(77046-100)