SANITARY WIPES- didecyl dimethyl ammonium chloride cloth 
75% ALCOHOL SANITARY WIPES- alcohol cloth 
Shandong Green Huineng Technology 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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75% alcohol sanitary wipes; Sanitary wipes

75% alcohol sanitary wipes

Sanitary wipes

Active Ingredient(s)

75% alcohol sanitary wipes: Alcohol 3.15mL/pcs. Purpose: Antiseptic

Sanitary wipes: Didecyl dimethyl ammonium chloride 0.00168mg/pcs; benzalkonium chloride 0.00189mg/pcs Purpose: Antiseptic

Purpose

Antiseptic

Use

75% alcohol sanitary wipes, Sanitary wipes to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only.

Do not use

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 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.

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

Other information

Inactive ingredients

75% alcohol sanitary wipes:

WATER


Sanitary wipes:

WATER

Package Label - Principal Display Panel

101-1101-2102-1102-2

SANITARY WIPES 
didecyl dimethyl ammonium chloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81332-102
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B) (DIDECYLDIMONIUM - UNII:Z7F472XQPA) DIDECYLDIMONIUM CHLORIDE0.00168 mg
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.00189 mg
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81332-102-0150 in 1 PAIL; Type 0: Not a Combination Product12/22/2020
2NDC:81332-102-0280 in 1 PAIL; Type 0: Not a Combination Product12/22/2020
3NDC:81332-102-03100 in 1 PAIL; Type 0: Not a Combination Product12/22/2020
4NDC:81332-102-04150 in 1 PAIL; Type 0: Not a Combination Product12/22/2020
5NDC:81332-102-05200 in 1 PAIL; Type 0: Not a Combination Product12/22/2020
6NDC:81332-102-06250 in 1 PAIL; Type 0: Not a Combination Product12/22/2020
7NDC:81332-102-07300 in 1 PAIL; Type 0: Not a Combination Product12/22/2020
8NDC:81332-102-08500 in 1 PAIL; Type 0: Not a Combination Product12/22/2020
9NDC:81332-102-09800 in 1 PAIL; Type 0: Not a Combination Product12/22/2020
10NDC:81332-102-101200 in 1 PAIL; Type 0: Not a Combination Product12/22/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A12/22/2020
75% ALCOHOL SANITARY WIPES 
alcohol cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81332-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL3.15 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81332-101-0150 in 1 PAIL; Type 0: Not a Combination Product12/22/2020
2NDC:81332-101-0280 in 1 PAIL; Type 0: Not a Combination Product12/22/2020
3NDC:81332-101-03100 in 1 PAIL; Type 0: Not a Combination Product12/22/2020
4NDC:81332-101-04150 in 1 PAIL; Type 0: Not a Combination Product12/22/2020
5NDC:81332-101-05200 in 1 PAIL; Type 0: Not a Combination Product12/22/2020
6NDC:81332-101-06250 in 1 PAIL; Type 0: Not a Combination Product12/22/2020
7NDC:81332-101-07300 in 1 PAIL; Type 0: Not a Combination Product12/22/2020
8NDC:81332-101-08500 in 1 PAIL; Type 0: Not a Combination Product12/22/2020
9NDC:81332-101-09800 in 1 PAIL; Type 0: Not a Combination Product12/22/2020
10NDC:81332-101-101200 in 1 PAIL; Type 0: Not a Combination Product12/22/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A12/22/2020
Labeler - Shandong Green Huineng Technology Co., Ltd. (554553759)
Establishment
NameAddressID/FEIBusiness Operations
Shandong Green Huineng Technology Co., Ltd.554553759manufacture(81332-101, 81332-102)

Revised: 6/2023
Document Id: fe778fed-286a-72de-e053-6394a90a610e
Set id: b707922a-2a11-98f4-e053-2995a90a7089
Version: 2
Effective Time: 20230619
 
Shandong Green Huineng Technology Co., Ltd.