75% ALCOHOL DISINFECTANT- 75% alcohol disinfectant liquid 
Guangzhou Guangyi Biotechnology 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)

Alcohol 75%

Purpose

Antiseptic

scope of use

applicable to object surface disinfection,hand and skin disinfection.

precautions

1.This product is a topical disinfectant,which should not be taken orally and should be kept out of reach of children.

2.The product is inflammable,keep away from the source of fire.

3. Alcohol allergy with caution.

4.Keep away from light,store in cool,dry and ventilated place and store in a sealed place.

5.It is not suitable for disinfecting the surface of fat-soluble object.

Do not use

  • in children less than 2 months of age
  • on open skin wounds

Use

1.skin disinfection:evenly apply the original solution twice for disinfection,using 1-3 minutes.

2.object surface disinfection:the original liquid evenly wipe or soak the disinfection items,using 1.5 to 3 minutes.

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

water

Effective period

24 months

Package Label - Principal Display Panel

50100300500

75% ALCOHOL DISINFECTANT 
75% alcohol disinfectant liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75197-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75197-005-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product04/17/2020
2NDC:75197-005-02100 mL in 1 BOTTLE; Type 0: Not a Combination Product04/17/2020
3NDC:75197-005-03300 mL in 1 BOTTLE; Type 0: Not a Combination Product04/17/2020
4NDC:75197-005-04500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/17/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/17/202001/14/2021
Labeler - Guangzhou Guangyi Biotechnology Co., Ltd. (419340725)
Establishment
NameAddressID/FEIBusiness Operations
Guangzhou Guangyi Biotechnology Co., Ltd.419340725manufacture(75197-005)

Revised: 1/2021
 
Guangzhou Guangyi Biotechnology Co., Ltd.