77720-008 HAND SANITIZING WIPES 0.13% BENZALKONIUM CHLORIDE

HAND SANITIZING WIPES by

Drug Labeling and Warnings

HAND SANITIZING WIPES by is a Otc medication manufactured, distributed, or labeled by Skaffles Group Limited Liability Company, Zhejiang Youquan Care Supplies Technology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZING WIPES- benzalkonium chloride cloth 
Skaffles Group Limited Liability Company

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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77720-008 HAND SANITIZING WIPES 0.13% BENZALKONIUM CHLORIDE

Active Ingredient

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

USE

For hand washing to decrease bacteria on the skin.
Recommended for repeated use.

Warning

For external use only. Do not use if you are allergic to
any of the ingredients.

Keep out of reach of children.

Directions

Directions● Adults and children 2 yrs and over,
apply to hands and allow skin to dry without wiping.
●Children under 2, ask doctor before use.

Inactive ingredients

Inactive ingredients Water, Aloe Barbadensis Leaf Juice,
PEG-75 Lanolin, Quatermium-52, PEG-8 Dimethicone, Disodium
Cocoamphodiacetate, Disodium EDTA, Chamomilla Recutita
(Matricaria) Flower Extract, Potassium Sorbate, Phenoxyethanol,
Cetylpyridinium Chloride, Sodium Benzoate, Citric Acid.

HAND SANITIZING WIPES 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77720-008
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 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
QUATERNIUM-52 (UNII: 588EQF3H1P)
PEG-75 LANOLIN (UNII: 09179OX7TB)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
PEG-8 DIMETHICONE (UNII: GIA7T764OD)
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)
CHAMOMILE (UNII: FGL3685T2X)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77720-008-01	10 in 1 BAG	09/15/2020
1		40.5 g in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 77720-008-02	15 in 1 BAG	09/15/2020
2		60.7 g in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 77720-008-03	20 in 1 BAG	09/15/2020
3		81 g in 1 POUCH; Type 0: Not a Combination Product
4	NDC: 77720-008-04	25 in 1 BAG	09/15/2020
4		101 g in 1 POUCH; Type 0: Not a Combination Product
5	NDC: 77720-008-05	30 in 1 BAG	09/15/2020
5		121 g in 1 POUCH; Type 0: Not a Combination Product
6	NDC: 77720-008-06	50 in 1 BAG	09/15/2020
6		202 g in 1 POUCH; Type 0: Not a Combination Product
7	NDC: 77720-008-07	75 in 1 CANISTER	09/15/2020
7		303 g in 1 POUCH; Type 0: Not a Combination Product
8	NDC: 77720-008-08	100 in 1 BAG	09/15/2020
8		405 g in 1 POUCH; Type 0: Not a Combination Product
9	NDC: 77720-008-09	1 in 1 BAG	09/15/2020
9		2.56 g in 1 POUCH; Type 0: Not a Combination Product
10	NDC: 77720-008-10	50 in 1 CANISTER	09/15/2020
10		202 g in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/15/2020	09/20/2020

Labeler - Skaffles Group Limited Liability Company (831115642)

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Youquan Care Supplies Technology Co., Ltd.		421318425	manufacture(77720-008)

Revised: 9/2020

Document Id: af8f4efc-b578-b449-e053-2a95a90ad659

34390-5

Set id: af8cc2b4-ef60-dcaa-e053-2a95a90abb16

Version: 2

Effective Time: 20200917