75% MEDICAL ALCOHOL- 75% medical alcohol liquid 
Xinxiang Xianfeng Medicine New Material 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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80874-001
75% MEDICAL ALCOHOL

Active Ingredient(s)

Ethanol 75%(V/V)

Purpose

Antiseptic

Use

Used to kill Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa, Candida albicans and other microorganisms.

Warnings

[Matters needing attention]
1.This product is for external use and should not be taken orally;
2.This product should be kept out of the reach of children;
3.This product is flammable and should be kept away from sources of ignition

[Taboo]
This product is not suitable for disinfecting the surface off at-soluble objects, and should be used with caution for those who are allergic to alcohol.

Do not use

/

1.It is suitable for disinfection of the surface of objects and the surface of human skin.
2.Take this product to wipe the surface of objects or the surface of human skin directly.Or use a medical cotton swab(or cotton ball) dipped in a little product to wipe.Act just for three minutes.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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Directions

Perennial exposure to high concentrations of this product can cause irritation of the nose, eyes, and mucous membranes as well as headache, dizziness, fatigue, irritability, tremor, nausea, etc.

Other information

The temperature of the warehouse should not exceed 30℃, keep the container seal

Inactive ingredients

Purified water 25%(V/V)

Package Label - Principal Display Panel

BOTTLE 80874-001-01 0.085kg

BOTTLE 80874-001-01 0.085kg

BOTTLE 80874-001-02 0.085kg BOTTLE 80874-001-02 0.085kg

BOTTLE 80874-001-03 0.425kg

BOTTLE 80874-001-03 0.425kg

DRUM 80874-001-04 20kg

DRUM 80874-001-04 20kg

DRUM 80874-001-05 165kg

DRUM 80874-001-05 165kg

DRUM 80874-001-06 800kg

DRUM 80874-001-06 800kg

75% MEDICAL ALCOHOL 
75% medical alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80874-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 kg  in 100 kg
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80874-001-010.085 kg in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
2NDC:80874-001-020.085 kg in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
3NDC:80874-001-0420 kg in 1 DRUM; Type 0: Not a Combination Product03/30/2020
4NDC:80874-001-05165 kg in 1 DRUM; Type 0: Not a Combination Product03/30/2020
5NDC:80874-001-030.425 kg in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
6NDC:80874-001-06800 kg in 1 DRUM; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - Xinxiang Xianfeng Medicine New Material Co., Ltd. (407962189)
Establishment
NameAddressID/FEIBusiness Operations
Xinxiang Xianfeng Medicine New Material Co., Ltd.407962189manufacture(80874-001)

Revised: 12/2020
Document Id: b6b3d50c-7161-2ab2-e053-2a95a90aa3f4
Set id: b6b3d50c-7171-2ab2-e053-2a95a90aa3f4
Version: 1
Effective Time: 20201217
 
Xinxiang Xianfeng Medicine New Material Co., Ltd.