80057-001 75％ alcohol Hand Sanitizing Wipes

Hand Sanitizing Wipes by

Drug Labeling and Warnings

Hand Sanitizing Wipes by is a Otc medication manufactured, distributed, or labeled by Zhejiang Bright Commodity Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZING WIPES- ethyl alcohol cloth 
Zhejiang Bright Commodity 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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80057-001 75％ alcohol Hand Sanitizing Wipes

Active ingredient

Ethy| Alcohol 75%

Purpose

Antiseptic

Use

Sanitizes Hands.

Warnings

For external use only
Flammable. Keep away from fire or flame.
When using this product
■do not use in or near the eyes. In case of contact with eyes flush
thoroughly with water.
use only on unbroken, intact skin
■if you have sensitive skin or certain allergies, check the list of
ingredients on the label before using
do not inhale or ingest
Stop use and ask a doctor if
skin irritation or redness develops
condition persists for more than 72 hours

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

■wipe hands thoroughly, let skin dry and discard
■for children under 6 years of age, use only under adult supervision
not recommended for infants

Water

HAND SANITIZING WIPES 
ethyl alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80057-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80057-001-10	160 in 1 CANISTER	08/20/2020
1		340.2 g in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 80057-001-01	10 in 1 PACKAGE	08/20/2020
2		30.62 g in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 80057-001-02	40 in 1 PACKAGE	08/20/2020
3		122.47 g in 1 POUCH; Type 0: Not a Combination Product
4	NDC: 80057-001-03	50 in 1 PACKAGE	08/20/2020
4		153.09 g in 1 POUCH; Type 0: Not a Combination Product
5	NDC: 80057-001-04	60 in 1 PACKAGE	08/20/2020
5		183.71 g in 1 POUCH; Type 0: Not a Combination Product
6	NDC: 80057-001-05	80 in 1 PACKAGE	08/20/2020
6		244.94 g in 1 POUCH; Type 0: Not a Combination Product
7	NDC: 80057-001-06	100 in 1 PACKAGE	08/20/2020
7		306.18 g in 1 POUCH; Type 0: Not a Combination Product
8	NDC: 80057-001-07	1 in 1 PACKAGE	08/20/2020
8		3.06 g in 1 POUCH; Type 0: Not a Combination Product
9	NDC: 80057-001-08	75 in 1 CANISTER	08/20/2020
9		159.47 g in 1 POUCH; Type 0: Not a Combination Product
10	NDC: 80057-001-09	100 in 1 CANISTER	08/20/2020
10		212.63 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	08/20/2020

Labeler - Zhejiang Bright Commodity Co., Ltd. (554544252)

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Bright Commodity Co., Ltd.		554544252	manufacture(80057-001)

Revised: 5/2023

Document Id: fad59b1e-9a77-1346-e053-6394a90a3af7

34390-5

Set id: ad441b53-53b0-c14a-e053-2995a90ae098

Version: 2

Effective Time: 20230503