81636-001 Isopropyl Alcohol Pad

Isopropyl Alcohol Pad by

Drug Labeling and Warnings

Isopropyl Alcohol Pad by is a Otc medication manufactured, distributed, or labeled by Zhejiang Xingheng medical supplies Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ISOPROPYL ALCOHOL PAD- isopropyl alcohol pad cloth 
Zhejiang Xingheng medical supplies 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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81636-001
Isopropyl Alcohol Pad

Active Ingredient(s)

isopropyl alcohol 70%

Purpose

Alcohol pad is composed of spun laced nonwoven sheet, 70% plus or minus 5% alcohol and coated paper packaging materials.

Use

apply the product to the skin, take the injection or puncture site as the center, slowly rotate from the inside to the outside, and gradually apply the product for two times, the disinfection area should be more than 5cmx5cm, and the action time should be1min.Please clean before disinfection.

Warnings

1.This product is for one-time use only.
2.Do not use the product when its packaging is damaged.
3.Use with caution if allergic to alcohol.
4.This product is flammable and should be kept away from the source of fire.

Do not use

Do not use the product when its packaging is damaged.

Do not use the product when its packaging is damaged.
Use with caution if allergic to alcohol.
This product is flammable and should be kept away from the source of fire.

Keep out of reach of children

/

Keep out of reach of children

Directions

Apply topically as needed to cleanse Intended area

Discard after single use

Keep out of reach of children

Other information

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

Inactive ingredients

water

Package Label - Principal Display Panel

81636-001-01 100 BOX in 1 CARTON

81636-001-02 100 CLOTH in 1 BOX

81636-001-03 0.4ml in 1 pouch

ISOPROPYL ALCOHOL PAD 
isopropyl alcohol pad cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81636-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	30 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81636-001-01	100 in 1 CARTON	03/30/2020
1	NDC: 81636-001-02	100 in 1 BOX
1	NDC: 81636-001-03	0.4 mL 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	03/30/2020

Labeler - Zhejiang Xingheng medical supplies Co., Ltd (554554581)

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Xingheng medical supplies Co., Ltd		554554581	manufacture(81636-001)

Revised: 1/2022

Document Id: d4e0f8be-5d91-50c0-e053-2a95a90a3e1a

34390-5

Set id: bcc49028-a30a-730c-e053-2a95a90abd31

Version: 9

Effective Time: 20220105

 

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