80057-002 75％ alcohol First Line Alcohol Wipes

First Line Alcohol Wipes by

Drug Labeling and Warnings

First Line Alcohol 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]

FIRST LINE ALCOHOL 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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80057-002 75％ alcohol First Line Alcohol Wipes

Active ingredient

Ethy| Alcohol 75%

Purpose

Antiseptic

Use

Topical antiseptic

Warnings

Flammable. Keep away from fire or flame.
For external use only.
Do not use
- in children less than 2 months in age
.on open skin wounds
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 redness develops
and lasts more than 72 hours
Keep out of reach of children. If swallowed, seek medical
help or contact a Poison Control Center right away.

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

.Wet hands thoroughly with product and allow to dry.
·Children under 6 years of age should be supervised.

Water,glycerin

2

FIRST LINE ALCOHOL WIPES 
ethyl alcohol cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 80057-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 80057-002-10160 in 1 CANISTER09/05/2020
1340.2 g in 1 POUCH; Type 0: Not a Combination Product
2NDC: 80057-002-0110 in 1 PACKAGE09/05/2020
230.62 g in 1 POUCH; Type 0: Not a Combination Product
3NDC: 80057-002-0240 in 1 PACKAGE09/05/2020
3122.47 g in 1 POUCH; Type 0: Not a Combination Product
4NDC: 80057-002-0350 in 1 PACKAGE09/05/2020
4153.09 g in 1 POUCH; Type 0: Not a Combination Product
5NDC: 80057-002-0460 in 1 PACKAGE09/05/2020
5183.71 g in 1 POUCH; Type 0: Not a Combination Product
6NDC: 80057-002-0580 in 1 PACKAGE09/05/2020
6244.94 g in 1 POUCH; Type 0: Not a Combination Product
7NDC: 80057-002-06100 in 1 PACKAGE09/05/2020
7306.18 g in 1 POUCH; Type 0: Not a Combination Product
8NDC: 80057-002-071 in 1 PACKAGE09/05/2020
83.06 g in 1 POUCH; Type 0: Not a Combination Product
9NDC: 80057-002-0870 in 1 CANISTER09/05/2020
9159.47 g in 1 POUCH; Type 0: Not a Combination Product
10NDC: 80057-002-09100 in 1 CANISTER09/05/2020
10212.63 g in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/05/2020
Labeler - Zhejiang Bright Commodity Co., Ltd. (554544252)
Establishment
NameAddressID/FEIBusiness Operations
Zhejiang Bright Commodity Co., Ltd.554544252manufacture(80057-002)

Revised: 5/2023
Document Id: fad64a8d-e58a-f3d4-e053-6294a90a0175
Set id: aeaef698-a213-bc1a-e053-2995a90ae7b0
Version: 2
Effective Time: 20230503